Michigan MPJE Exam UPDATED Exam
Questions and CORRECT Answers
Misbranding - CORRECT ANSWER - Drugs which are sold, dispensed or distributed in
violation of labeling requirements of FDCA
Adulterated or Misbranded?:
False/misleading labeling - CORRECT ANSWER - Misbranded
Adulterated or Misbranded?:
Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity
of drug - CORRECT ANSWER - Misbranded
Adulterated or Misbranded?:
Any word or statement required on label is not prominent, conspicuous and readable -
CORRECT ANSWER - Misbranded
Adulterated or Misbranded?:
Drug has habit-forming substance and label fails to list name and proportion of substance and
"Warning—may be habit forming" - CORRECT ANSWER - Misbranded
Adulterated or Misbranded?:
If established name or mutli-ingredient products don't identify each active ingredient -
CORRECT ANSWER - Misbranded
Adulterated or Misbranded?:
Drug is liable to deterioration and label doesn't warn to that effect - CORRECT ANSWER -
Misbranded
Adulterated or Misbranded?:
,Misleading container, imitates another drug or offered for sale under the name of another drug -
CORRECT ANSWER - Misbranded
Adulterated or Misbranded?:
Dosage, frequency, duration or route of admin suggested in the labeling is dangerous -
CORRECT ANSWER - Misbranded
Adulterated or Misbranded?:
Pharmacist dispensed a medication without a refill or prescription - CORRECT ANSWER -
Misbranded
Adulteration - CORRECT ANSWER - Failure of drug or device to satisfy FDA purity
standards
Adulterated or Misbranded?:
Consists in whole or in part of filthy, putrid or decomposed substance - CORRECT
ANSWER - Adulterated
Adulterated or Misbranded?:
Prepared, packaged or held under unsanitary conditions, whereby it MAY have become
contaminated w/ filth or MAY have been rendered injurious to health (don't have to prove, just
say it MAY have) - CORRECT ANSWER - Adulterated
Adulterated or Misbranded?:
Drug is manufactured in facility in violation of cGMPs - CORRECT ANSWER - Adulterated
Adulterated or Misbranded?:
Container is composed of poisonous or deleterious substance that may render contains injurious
to health - CORRECT ANSWER - Adulterated
,Adulterated or Misbranded?:
Bears unsafe color additive for purposes of coloring only - CORRECT ANSWER -
Adulterated
Adulterated or Misbranded?:
Drug labeled in official compendium but strength differs from or quality or purity falls below
compendium standards - CORRECT ANSWER - Adulterated
Adulterated or Misbranded?:
Drug not listed in official compendium and its strength differs from or its quality or purity falls
below what is represented on label - CORRECT ANSWER - Adulterated
Adulterated or Misbranded?:
Any substance mixed w/ the drug to reduce strength, or any substance that has been substituted
for the drug - CORRECT ANSWER - Adulterated
Adulterated or Misbranded?:
Pharmacist dispenses expired products - CORRECT ANSWER - Adulterated
Labeling - CORRECT ANSWER - Anything accompanying the product (ex: package insert,
med guide, advertisements, physician's desk reference, side effects statement, promotional
material, the actual label, etc.)
OTC Labeling - minimum font size? - CORRECT ANSWER - Size 6
Federal Food Drug & Cosmetic (FDC) Act - CORRECT ANSWER - -Required new drugs to
be shown safe before marketing
-Authorized factory inspections
Prescription Drug Marketing Act - CORRECT ANSWER - -Bans the sale of samples
, -Requires drug wholesalers to be licensed by the states
-Restricts reimportation from other countries
Michigan Board of Pharmacy Members - CORRECT ANSWER - 11 members - 6 RPh and 5
Public
Michigan Board of Pharmacy Disciplinary Subcommittee - CORRECT ANSWER - -2 public
and 3 professional members
-Vote on disciplinary actions
-Must have 1 public member to vote along with the majority for a decision to be made (gives the
public members a "super vote")
Package Insert - CORRECT ANSWER - -Contains essential information for safe and effective
use of the drug (Ex. Black Box Warnings)
-Can give to the patient
Patient Package Insert - CORRECT ANSWER - -Community or outpatient pharmacies must
give with every dispensing for the drugs that require one (ex: estrogen products)
-Institutional law: must be given before the first administration and every 30 days
-Physician canNOT opt out for a patient
-It is considered misbranded if not given
Medication Guide - CORRECT ANSWER - -Required by FDA on certain products that cause
"a serious and significant public health concern"
-Required in the community setting with EVERY dispensing (misbranded if not given)
-Physician CAN request the patient does not receive one but patient can override this request
-Institutional setting: it's unnecessary to dispense b/c there's a professional available at all times
to answer questions.
Consumer Medication Information - CORRECT ANSWER - -Not a requirement
Questions and CORRECT Answers
Misbranding - CORRECT ANSWER - Drugs which are sold, dispensed or distributed in
violation of labeling requirements of FDCA
Adulterated or Misbranded?:
False/misleading labeling - CORRECT ANSWER - Misbranded
Adulterated or Misbranded?:
Packaging fails to identify name & address of manufacturer, packager of distributor, and quantity
of drug - CORRECT ANSWER - Misbranded
Adulterated or Misbranded?:
Any word or statement required on label is not prominent, conspicuous and readable -
CORRECT ANSWER - Misbranded
Adulterated or Misbranded?:
Drug has habit-forming substance and label fails to list name and proportion of substance and
"Warning—may be habit forming" - CORRECT ANSWER - Misbranded
Adulterated or Misbranded?:
If established name or mutli-ingredient products don't identify each active ingredient -
CORRECT ANSWER - Misbranded
Adulterated or Misbranded?:
Drug is liable to deterioration and label doesn't warn to that effect - CORRECT ANSWER -
Misbranded
Adulterated or Misbranded?:
,Misleading container, imitates another drug or offered for sale under the name of another drug -
CORRECT ANSWER - Misbranded
Adulterated or Misbranded?:
Dosage, frequency, duration or route of admin suggested in the labeling is dangerous -
CORRECT ANSWER - Misbranded
Adulterated or Misbranded?:
Pharmacist dispensed a medication without a refill or prescription - CORRECT ANSWER -
Misbranded
Adulteration - CORRECT ANSWER - Failure of drug or device to satisfy FDA purity
standards
Adulterated or Misbranded?:
Consists in whole or in part of filthy, putrid or decomposed substance - CORRECT
ANSWER - Adulterated
Adulterated or Misbranded?:
Prepared, packaged or held under unsanitary conditions, whereby it MAY have become
contaminated w/ filth or MAY have been rendered injurious to health (don't have to prove, just
say it MAY have) - CORRECT ANSWER - Adulterated
Adulterated or Misbranded?:
Drug is manufactured in facility in violation of cGMPs - CORRECT ANSWER - Adulterated
Adulterated or Misbranded?:
Container is composed of poisonous or deleterious substance that may render contains injurious
to health - CORRECT ANSWER - Adulterated
,Adulterated or Misbranded?:
Bears unsafe color additive for purposes of coloring only - CORRECT ANSWER -
Adulterated
Adulterated or Misbranded?:
Drug labeled in official compendium but strength differs from or quality or purity falls below
compendium standards - CORRECT ANSWER - Adulterated
Adulterated or Misbranded?:
Drug not listed in official compendium and its strength differs from or its quality or purity falls
below what is represented on label - CORRECT ANSWER - Adulterated
Adulterated or Misbranded?:
Any substance mixed w/ the drug to reduce strength, or any substance that has been substituted
for the drug - CORRECT ANSWER - Adulterated
Adulterated or Misbranded?:
Pharmacist dispenses expired products - CORRECT ANSWER - Adulterated
Labeling - CORRECT ANSWER - Anything accompanying the product (ex: package insert,
med guide, advertisements, physician's desk reference, side effects statement, promotional
material, the actual label, etc.)
OTC Labeling - minimum font size? - CORRECT ANSWER - Size 6
Federal Food Drug & Cosmetic (FDC) Act - CORRECT ANSWER - -Required new drugs to
be shown safe before marketing
-Authorized factory inspections
Prescription Drug Marketing Act - CORRECT ANSWER - -Bans the sale of samples
, -Requires drug wholesalers to be licensed by the states
-Restricts reimportation from other countries
Michigan Board of Pharmacy Members - CORRECT ANSWER - 11 members - 6 RPh and 5
Public
Michigan Board of Pharmacy Disciplinary Subcommittee - CORRECT ANSWER - -2 public
and 3 professional members
-Vote on disciplinary actions
-Must have 1 public member to vote along with the majority for a decision to be made (gives the
public members a "super vote")
Package Insert - CORRECT ANSWER - -Contains essential information for safe and effective
use of the drug (Ex. Black Box Warnings)
-Can give to the patient
Patient Package Insert - CORRECT ANSWER - -Community or outpatient pharmacies must
give with every dispensing for the drugs that require one (ex: estrogen products)
-Institutional law: must be given before the first administration and every 30 days
-Physician canNOT opt out for a patient
-It is considered misbranded if not given
Medication Guide - CORRECT ANSWER - -Required by FDA on certain products that cause
"a serious and significant public health concern"
-Required in the community setting with EVERY dispensing (misbranded if not given)
-Physician CAN request the patient does not receive one but patient can override this request
-Institutional setting: it's unnecessary to dispense b/c there's a professional available at all times
to answer questions.
Consumer Medication Information - CORRECT ANSWER - -Not a requirement
