PHA 650A MPJE (GA): EXAM 1-6, FINAL EXAM, &
NABP: PRE-MPJE REAL EXAM QUESTIONS WITH
ANSWERS LATEST UPDATE
Orphan drugs are used to treat rare diseases. What criteria does the drug need to meet
in order to be considered an orphan drug? (SATA)
a. The targeted disease must affect less than 200,000 people in the US.
b. The targeted disease affects less than 1% of the U.S. population
c. A drug in which there is no reasonable expectation that sales will make up for the
development costs
d. The target disease must affect less than 200,000 people worldwide
--ANSWER--a. The targeted disease must affect less than 200,000 people in the US
--
c. A drug in which there is no reasonable expectation that sales will make up for the
development costs
--
Which clinical trial phase is conducted after the drug is already on the market?
Phase IV
Which clinical trial phase is the first to be conducted on human subjects?
Phase I
The drug Clorinex has the following National Drug Code: 0085-1264-02. What do the
numbers "02" represent?
Package size
Page | 1
,The definitions for food, drugs, dietary supplements and devices were initially defined under
this act:
The Food, Drugs, and Cosmetics Act (FDCA) of 1938
The drug labeling information requiremnts for pregnancy and nursing were changed in
2015. The previous pregnancy categories of A, B, C, D, and X are being phased out.
What are the names of the sections that must be included in the new labeling? (SATA)
a. Females and Males of Reproductive Potential
b. Labor and Delivery
c. Nursing Mothers
d. Lactation
e. Pregnancy
Pending (i.e. Mercer faculty never followed up with correct answer(s) nor reasoning)
Answered A, D, and E and got it wrong.
WOTF statements is true for the package insert of a legened drug? (SATA)
a. It is prohibited from being given to a patient upon request
b. It must be approved by the FDA
c. It is intended for the healthcare provider
d. It should include safety information on any known health risks if taken during pregnancy
e. It should be written at approximately an eighth-grade comprehension level
--
--ANSWER--b. It must be approved by the FDA
c. It is intended for the healthcare provider
d. It should include safety information on any known health risks if taken during pregnancy
Page | 2
,--
EyeMerica drug company would like to make a generic version of a prescription drug product
with an expired exclusivity period. Which type of application must EyeMerica submit to the
Food and Drug Administration?
ANDA
A pharmaceutical company would like to market a new dosage for a drug. Which type of
application must the pharmaceutical company submit to the Food and Drug Administration?
sNDA
WOTF is TRUE regarding FDA regulations that require “adequate directions for use?”
a. These are required for prescription drugs only and not required for OTC products.
b. They mandate that directions must be written clearly so that a layperson can use the OTC
drug safely for appropriate purposes.
c. They mandate that the instruction be written at an eighth-grade level.
d. They do not need to include either the dosing, preparation, frequency, duration, time, and
route of administration if the product is in common use as an OTC product; this is at the
discretion of the manufacturer.
--ANSWER--b. They mandate that directions must be written clearly so that a layperson can
use the OTC drug safely for appropriate purposes.
A drug company is marketing an over-the-counter drug Coldimmune Health Formula as a
product that will prevent colds. Which regulatory body is responsible for enforcing the
accuracy of this claim?
Federal Trade Commission
Each of the following statements concerning the NDC number is correct EXCEPT:
a. The third segment identifies the package size of the drug
b. The first segment identifies the company that prepared the drug or packaged it.
Page | 3
, c. NDC stands for National Drug Code
d. The second segment identifies the strength, dosage and formulation of the drug
e. NDCs identify prescription drugs only; OTC drugs are not assigned NDC numbers.
--ANSWER--e. NDCs identify prescription drugs only; OTC drugs are not assigned NDC
numbers.
A unit dose label for Invokana does not have a beyond use date (BUD) on it. The drug is
considered: (SATA)
a. Ok to dispense
b. Misbranded
c. Adulterated
d. Expired
Pending (i.e. Mercer faculty never followed up with correct answer(s) nor reasoning)
Answered only "b. misbranded" and got it wrong
WOTF drugs is considered "misbranded"? (SATA)
a. An insulin vial is stored at room temperature for over 60 days and contents appeared
discolored
b. The manufacturer’s container is labeled as containing 100 tablets, but the bottle only
contains 80
c. The manufacturer’s label on a container of metformin is missing the statement “Rx only”
d. Filling a drug in a dirty vial
e. A compounded drug prepared in a pharmacy with rat droppings on the floor
--
--ANSWER--
b. The manufacturer's container is labeled as containing 100 tablets, but the bottle only
contains 80
Page | 4
NABP: PRE-MPJE REAL EXAM QUESTIONS WITH
ANSWERS LATEST UPDATE
Orphan drugs are used to treat rare diseases. What criteria does the drug need to meet
in order to be considered an orphan drug? (SATA)
a. The targeted disease must affect less than 200,000 people in the US.
b. The targeted disease affects less than 1% of the U.S. population
c. A drug in which there is no reasonable expectation that sales will make up for the
development costs
d. The target disease must affect less than 200,000 people worldwide
--ANSWER--a. The targeted disease must affect less than 200,000 people in the US
--
c. A drug in which there is no reasonable expectation that sales will make up for the
development costs
--
Which clinical trial phase is conducted after the drug is already on the market?
Phase IV
Which clinical trial phase is the first to be conducted on human subjects?
Phase I
The drug Clorinex has the following National Drug Code: 0085-1264-02. What do the
numbers "02" represent?
Package size
Page | 1
,The definitions for food, drugs, dietary supplements and devices were initially defined under
this act:
The Food, Drugs, and Cosmetics Act (FDCA) of 1938
The drug labeling information requiremnts for pregnancy and nursing were changed in
2015. The previous pregnancy categories of A, B, C, D, and X are being phased out.
What are the names of the sections that must be included in the new labeling? (SATA)
a. Females and Males of Reproductive Potential
b. Labor and Delivery
c. Nursing Mothers
d. Lactation
e. Pregnancy
Pending (i.e. Mercer faculty never followed up with correct answer(s) nor reasoning)
Answered A, D, and E and got it wrong.
WOTF statements is true for the package insert of a legened drug? (SATA)
a. It is prohibited from being given to a patient upon request
b. It must be approved by the FDA
c. It is intended for the healthcare provider
d. It should include safety information on any known health risks if taken during pregnancy
e. It should be written at approximately an eighth-grade comprehension level
--
--ANSWER--b. It must be approved by the FDA
c. It is intended for the healthcare provider
d. It should include safety information on any known health risks if taken during pregnancy
Page | 2
,--
EyeMerica drug company would like to make a generic version of a prescription drug product
with an expired exclusivity period. Which type of application must EyeMerica submit to the
Food and Drug Administration?
ANDA
A pharmaceutical company would like to market a new dosage for a drug. Which type of
application must the pharmaceutical company submit to the Food and Drug Administration?
sNDA
WOTF is TRUE regarding FDA regulations that require “adequate directions for use?”
a. These are required for prescription drugs only and not required for OTC products.
b. They mandate that directions must be written clearly so that a layperson can use the OTC
drug safely for appropriate purposes.
c. They mandate that the instruction be written at an eighth-grade level.
d. They do not need to include either the dosing, preparation, frequency, duration, time, and
route of administration if the product is in common use as an OTC product; this is at the
discretion of the manufacturer.
--ANSWER--b. They mandate that directions must be written clearly so that a layperson can
use the OTC drug safely for appropriate purposes.
A drug company is marketing an over-the-counter drug Coldimmune Health Formula as a
product that will prevent colds. Which regulatory body is responsible for enforcing the
accuracy of this claim?
Federal Trade Commission
Each of the following statements concerning the NDC number is correct EXCEPT:
a. The third segment identifies the package size of the drug
b. The first segment identifies the company that prepared the drug or packaged it.
Page | 3
, c. NDC stands for National Drug Code
d. The second segment identifies the strength, dosage and formulation of the drug
e. NDCs identify prescription drugs only; OTC drugs are not assigned NDC numbers.
--ANSWER--e. NDCs identify prescription drugs only; OTC drugs are not assigned NDC
numbers.
A unit dose label for Invokana does not have a beyond use date (BUD) on it. The drug is
considered: (SATA)
a. Ok to dispense
b. Misbranded
c. Adulterated
d. Expired
Pending (i.e. Mercer faculty never followed up with correct answer(s) nor reasoning)
Answered only "b. misbranded" and got it wrong
WOTF drugs is considered "misbranded"? (SATA)
a. An insulin vial is stored at room temperature for over 60 days and contents appeared
discolored
b. The manufacturer’s container is labeled as containing 100 tablets, but the bottle only
contains 80
c. The manufacturer’s label on a container of metformin is missing the statement “Rx only”
d. Filling a drug in a dirty vial
e. A compounded drug prepared in a pharmacy with rat droppings on the floor
--
--ANSWER--
b. The manufacturer's container is labeled as containing 100 tablets, but the bottle only
contains 80
Page | 4
