MPJE – Michigan Questions And Answers
100% Verified.
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
-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
-It's printed consumer medication information provided to patients at the time a new Rx
is filled
HIPAA Privacy Policy - correct answer. -Notice given to every individual
, -Good faith effort to obtain the patient's written acknowledgment of the receipt of the
notice
OBRA 90 and the Michigan "counseling rule" - correct answer. -OBRA 90: Requires
pharmacists to offer to counsel ALL Medicaid patients or caregiver on the first fill of a
new medication (and on refills if deemed necessary)
-Counseling Rule: Michigan requires the ALL patients or caregiver (regardless of
insurance carrier) being counseled on the first fill of a new medication.
-NOTE: Info shall be provided if requested for any Rx by the patient or patient's
caregiver or agent
OBRA 90: Items to discuss with patient - correct answer. -Name and description of
the medication
-Route, dosage form, dosage, and duration of drug therapy
-Special directions and precautions
-Common, severe side effects or drug interactions
-Techniques for self-monitoring drug therapy and actions required
-Proper storage
-Prescription refill information
-Action to be taken in the event of a missed dose
OBRA 90: Items needed for maintaining records - correct answer. -Name, address,
phone number, DOB (or age), gender
-RPh comments relevant to the client's drug therapy
-Patient history when significant, disease states, known allergies, and drug reactions
-Comprehensive list of medications and relevant devices
-Offer to counsel the patient—they can accept or reject the offer
Drugs Exempt from Childproof Packaging - correct answer. Sublingual Nitroglycerin,
Potassium supplements, Isosorbide dinitrate 10mg or less (SL or chewable),
Erythromycin, Anhydrous cholestyramine (powder), Sodium Fluoride, Betamethasone,
Mebendazole, Cholestipol, Prednisone, Norethindrone acetate, Medroxyprogesterone,
Sucrase, Methylprednisone, Pancrelipase, Oral contraceptives / Estrogen replacement
therapy (HRT)
NDC Number Requirements - correct answer. Required on all Rx and OTC products
When can non-child resistant packaging be used? - correct answer. -Dispensing to
patients in a nursing home/hospital
-Drugs to be administered by institutional personnel
-Samples, Starter packs
-Topical application
-Dosage form not intended for oral administration
-Bulk containers received by the pharmacy
-Unit dose packaging (birth control)
