INDIANA MPJE
EXAM QUESTIONS
AND ANSWERS
Although used in animals, prescription drugs are only approved for use in humans. a.
True
b. False - answer- a
Which of the following are included in both the definition of drug and the definition of
device? (Select all that apply)
a. Found in the USP
b. Does not achieve its primary intended purpose through chemical action and which is
not dependent upon being metabolized for the achievement of its primary intended
purpose
c. Found in the NF
d. Intended for use in the cure, mitigation, treatment, or prevention of disease in man or
other animal
e. Found in the HPUS - answer- a c d
A new drug that requires lab tests to monitor for adverse events at normal doses would
likely be approved as an over-the-counter drug.
a. True
b. False - answer- b
Products compounded by pharmacies are not held to the same requirements for cGMP,
misbranding, and new drug approval as marketed products.
a. True
b. False - answer- a
A manufacturer recently recalled a specific lot of prescription birth control that had the
,pills in reverse order. Which type of recall has most likely been issued?
a. Class I
b. Class II
c. Class III
d. Class IV
e. They're unlikely to issue a specific type of recall. - answer- b
Select all of the following situations that would NOT be considered adulteration.
a. A pharmacy repackages a drug and forgets to place an expiration date on the label.
b. A company follows cGMP when manufacturing a product.
c. A drug product doesn't conform to compendial standards but is labeled "not USP."
d. A drug product has a lower strength than what the label says.
e. A drug product in a container that is radioactive. - answer- b c
Select all of the following situations that would be considered misbranding.
a. An oral controlled substance is not dispensed in child-resistant packaging.
b. A brand name drug lists the generic on the label.
c. A drug product can develop a precipitate, and there are warnings included in the
package insert.
d. A prescription drug is dispensed without a prescription.
e. A drug product is manufactured with an unsafe coloring agent. - answer- a d
A Class I device is the most complicated device type and requires premarket approval.
a. True
b. False - answer- b
A surgeon is not allowed to write a prescription for a non-surgical issue.
a. True
b. False - answer- b
Which of the following are correct regarding a drug, max refills, and max prescription
validity?
a. Codeine/Acetaminophen, 0 refills, expires 6 months
b. Codeine, 5 refills, expires 1 year
c. Gabapentin, 5 refills, expires 6 months
d. Lisinopril, unlimited refills, expires 1 year
e. Sertraline, 11 refills, expires 1 year - answer- d
Pharmacists must determine whether an agent calling in a prescription has agency from
the practitioner.
a. True
b. False - answer- b
A prescription is presented to you on 2/25/2020 with the following information written on
it by Dr. Jane Doe. John Smith, Methadone 5mg, Take 1 tablet by mouth daily, may
, cause drowsiness. Select all of the following examples that include all information that
must be on the prescription label based on the prescription.
a. Name and address of pharmacy, Jane Doe, John Smith, Rx number, Methadone
5mg, 02/25/2020, Take 1 tablet by mouth daily, may cause drowsiness
b. Name and address of pharmacy, Jane Doe, Rx number, Methadone 5mg, Take 1
tablet by mouth daily
c. John Smith, Rx number, 02/25/2020, Methadone 5mg, Take 1 tablet by mouth daily,
may cause drowsiness
d. Name and address of pharmacy, Jane Doe, Rx number, 02/25/2020, Methadone 5mg
c. Jane Doe, John Smith, Rx number, Methadone 5mg, Take 1 tablet by mouth daily,
may cause drowsiness - answer- a
Medication guides are part of required labeling for drugs with serious risks associated
with their use.
a. True
b. False - answer- a
Which of the following is true regarding the Poison Prevention Packaging Act?
a. Child-resistant containers are required for all manufacturer produced drug products
b. The Consumer Product Safety Commission provides full exemptions of drugs
c. Prescribers can issue blanket waivers for a patient
d. There are no set standards for what is or what is not special packaging
e. All children should struggle to open child-resistant containers - answer- b
Information listed in USP chapters 795 and 797 is required to be followed if adopted as
part of the law federally or in your state of practice but is otherwise unnecessary
information.
a. True
b. False - answer- b
Which of the following is not a crime created by the Tamper-Evident Packaging On
Consumer Products Act (Anti-Tampering Act)?
a. Opening a bottle of OTC pain reliever to see what the tablets look like and placing it
back on a shelf for sale.
b. Placing a tablet you made in a bottle of OTC cough suppressant
c. Removing the shrink wrap from a prescription-only product
d. Calling the police to report that an OTC product has been tampered with when it
has not been.
e. Planning to switch the liquid in an OTC eye drop to rubbing alcohol as a prank with
your two friends - answer- c
Which of the following is inaccurate about the Dietary Supplement Health and Education
Act?
a. All dietary supplement containers must contain a disclaimer
b. Products may claim a benefit related to a classical nutrient deficiency without being
declared a drug