PHARMACY LAW MPJE EXAM: FEDERAL LAW – 250 PRACTICE
QUESTIONS WITH CORRECT ANSWERS | MULTISTATE PHARMACY
JURISPRUDENCE REVIEW COVERING THE LATEST TESTED
QUESTIONS
THE FEDERAL LAW SECTION OF THE MPJE EXAM EVALUATES
KNOWLEDGE OF NATIONAL PHARMACY REGULATIONS THAT GOVERN
PRESCRIBING, DISPENSING, AND DISTRIBUTION OF MEDICATIONS.
THIS RESOURCE IS ESSENTIAL FOR CANDIDATES SEEKING TO MEET
STATE LICENSING REQUIREMENTS WHILE DEMONSTRATING
COMPLIANCE WITH U.S. PHARMACY LAW AND PROFESSIONAL
STANDARDS.
What did the Pure Food and Drug Act of 1906 do? - CORRECT ANSWER-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 1938) - CORRECT ANSWER-Provides
for the comprehensive regulation of all drugs introduced into interstate (and 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 - CORRECT ANSWER-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 in trouble with the government too?
What about the a lawsuit with a patient? - CORRECT ANSWER-Yes, you can have an
administrative lawsuit, a civil lawsuit, and a criminal lawsuit separately for the same offense
,What did the Durham-Humphrey Amendment of 1951 do? - CORRECT ANSWER-Established 2
classes of drugs; prescription and OTC
What are the current requirements for patient package inserts? - CORRECT ANSWER-Was
mandated that the manufacturer must provider these for patients. However, the FDA changed this
and now private sector package inserts are used instead of government-mandated programs.
Pharmacies are exempt from registering as manufacturers if they do not - CORRECT ANSWER-
"Manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the
regular course of their business of dispensing or selling drugs or devices at retail."
If pharmacies repackage OTC products or change the wrapper, contain, or labeling, this is considered
- CORRECT ANSWER-Manufacturing
Can pharmacies repackage prescription products for sale to other healthcare providers? -
CORRECT ANSWER-No; this would be manufacturing
If a drug goes off the market can you compound it? - CORRECT ANSWER-No
Can you compound drugs ahead of time? - CORRECT ANSWER-Yes, as long as you expect to
receive prescriptions for these agents and the quantity is limited
Can you compound for third-party resale? - CORRECT ANSWER-No, you cannot compound
without a prescription
Can you compound drugs that are commercially available or that are essentially copies of agents
that are commercially available? - CORRECT ANSWER-No, however, you may compound a drug
that is only slightly different than a commercially available product as long and there is a legitimate
medical need to do so
Does this mean you have to get an NDA for a compounded drug? - CORRECT ANSWER-No,
compounding is exempt from the requirements as long as the pharmacy does not cross the line into
manufacturing
, Can you compound an OTC drug? - CORRECT ANSWER-Only with a prescription
Can you label a generic drug with it's brand name only? - CORRECT ANSWER-No
What is the FDA resource that is used to tell if 2 drugs are generically equivalent - CORRECT
ANSWER-Orange Book
What form is needed to create a generic drug? - CORRECT ANSWER-Abbreviated New Drug
Application (ANDA)
The first company to come out with a generic acquires an exclusivity period of - CORRECT
ANSWER-180 days
What is the definition of a Narrow Therapeutic Index (NTI) drug - CORRECT ANSWER-Where
there is less than a 2 fold difference between the median lethal dose and the median effective dose
Or
Where there is less than a 2 fold difference between the minimum toxic concentrations and the
minimum effective concentrations
A hospital may not sale, purchase, or trade prescription drugs unless - CORRECT ANSWER-1) It
is from a group purchasing organization or from other member hospitals for use at that hospital
2) Sold to a nonprofit affiliate
3) Sold to a hospital or other entity under common control
4) Sales or purchases for emergency reasons
5) Selling or dispensing pursuant to prescriptions
Can you import drugs into the country? - CORRECT ANSWER-Generally the importation of
prescription drugs from another country is illegal; FDA has permitted the importation of small
QUESTIONS WITH CORRECT ANSWERS | MULTISTATE PHARMACY
JURISPRUDENCE REVIEW COVERING THE LATEST TESTED
QUESTIONS
THE FEDERAL LAW SECTION OF THE MPJE EXAM EVALUATES
KNOWLEDGE OF NATIONAL PHARMACY REGULATIONS THAT GOVERN
PRESCRIBING, DISPENSING, AND DISTRIBUTION OF MEDICATIONS.
THIS RESOURCE IS ESSENTIAL FOR CANDIDATES SEEKING TO MEET
STATE LICENSING REQUIREMENTS WHILE DEMONSTRATING
COMPLIANCE WITH U.S. PHARMACY LAW AND PROFESSIONAL
STANDARDS.
What did the Pure Food and Drug Act of 1906 do? - CORRECT ANSWER-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 1938) - CORRECT ANSWER-Provides
for the comprehensive regulation of all drugs introduced into interstate (and 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 - CORRECT ANSWER-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 in trouble with the government too?
What about the a lawsuit with a patient? - CORRECT ANSWER-Yes, you can have an
administrative lawsuit, a civil lawsuit, and a criminal lawsuit separately for the same offense
,What did the Durham-Humphrey Amendment of 1951 do? - CORRECT ANSWER-Established 2
classes of drugs; prescription and OTC
What are the current requirements for patient package inserts? - CORRECT ANSWER-Was
mandated that the manufacturer must provider these for patients. However, the FDA changed this
and now private sector package inserts are used instead of government-mandated programs.
Pharmacies are exempt from registering as manufacturers if they do not - CORRECT ANSWER-
"Manufacture, prepare, propagate, compound, or process drugs or devices for sale other than in the
regular course of their business of dispensing or selling drugs or devices at retail."
If pharmacies repackage OTC products or change the wrapper, contain, or labeling, this is considered
- CORRECT ANSWER-Manufacturing
Can pharmacies repackage prescription products for sale to other healthcare providers? -
CORRECT ANSWER-No; this would be manufacturing
If a drug goes off the market can you compound it? - CORRECT ANSWER-No
Can you compound drugs ahead of time? - CORRECT ANSWER-Yes, as long as you expect to
receive prescriptions for these agents and the quantity is limited
Can you compound for third-party resale? - CORRECT ANSWER-No, you cannot compound
without a prescription
Can you compound drugs that are commercially available or that are essentially copies of agents
that are commercially available? - CORRECT ANSWER-No, however, you may compound a drug
that is only slightly different than a commercially available product as long and there is a legitimate
medical need to do so
Does this mean you have to get an NDA for a compounded drug? - CORRECT ANSWER-No,
compounding is exempt from the requirements as long as the pharmacy does not cross the line into
manufacturing
, Can you compound an OTC drug? - CORRECT ANSWER-Only with a prescription
Can you label a generic drug with it's brand name only? - CORRECT ANSWER-No
What is the FDA resource that is used to tell if 2 drugs are generically equivalent - CORRECT
ANSWER-Orange Book
What form is needed to create a generic drug? - CORRECT ANSWER-Abbreviated New Drug
Application (ANDA)
The first company to come out with a generic acquires an exclusivity period of - CORRECT
ANSWER-180 days
What is the definition of a Narrow Therapeutic Index (NTI) drug - CORRECT ANSWER-Where
there is less than a 2 fold difference between the median lethal dose and the median effective dose
Or
Where there is less than a 2 fold difference between the minimum toxic concentrations and the
minimum effective concentrations
A hospital may not sale, purchase, or trade prescription drugs unless - CORRECT ANSWER-1) It
is from a group purchasing organization or from other member hospitals for use at that hospital
2) Sold to a nonprofit affiliate
3) Sold to a hospital or other entity under common control
4) Sales or purchases for emergency reasons
5) Selling or dispensing pursuant to prescriptions
Can you import drugs into the country? - CORRECT ANSWER-Generally the importation of
prescription drugs from another country is illegal; FDA has permitted the importation of small
