Indiana MPJE Exam Review Questions Consisting Of 111 Questions With Verified Answers From Experts
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Indiana MPJE
Indiana MPJE Exam Review Questions Consisting Of 111 Questions With Verified Answers From Experts
Which federal act discusses adulteration and misbranding of drugs?
Food Drug and Cosmetic Act
T/F Adulteration/Misbranding can occur with both a drug and a device.
True
T/F A drug must be contam...
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Indiana MPJE Exam Review Questions 2022/2023 |
Consisting Of 111 Questions With Verified Answers From
Experts
Which federal act discusses adulteration and misbranding of drugs?
Food Drug and Cosmetic Act
T/F Adulteration/Misbranding can occur with both a drug and a device.
True
T/F A drug must be contaminated to be considered adulterated.
F - if held under unsanitary conditions where it MAYA have been contaminated
A container that contains a drug is made of poisonous or harmful materials.
However, there is no harm to the drugs inside the container. Is the drug
considered adulterated?
Yes
T/F: If a product does not meet standards of USP, but plainly states on it's label
"Not USP" it is not considered adulterated.
True - can deviate from USP standards if it says on package plainly "Not USP"
T/F If quality or purity falls above the stated amount on the bottle it is considered
adulterated.
False - no only considered adulterated if it falls below purity/quality stated
T/F If a strength of a drug does not match what is stated on the bottle, it is both
adulterated and misbranded.
True
T/F: Providing a drug product other than the one that is written on the bottle is
considered misbranding only.
False - Misbranding and Adulteration
An Rx product dispensed directly to a patient is misbranding when it does not
contain name and place of business of the manufacturer, packer, and/or
distributor.
False - commercial products must contain this, but not Rx products dispensed to a
patient do not have to have this
A commercial product must accurately contain the quantity listed on the bottle,
but an Rx dispensed directly to a patient does not have to have this information
on it.
True - considered misbranding if a commercial product does not have an accurate
quantity listed on it
On a commercial product, generic names but be _______ the height of the brand
name.
Half
If a legend drug is dispensed without a prescription or drug order, it is
considered misbranding.
True
If a drug may decompose, it must state this on the label or it is considered
misbranding.
True
, A drug dispensed after the written Rx has expired is considered adulteration.
False - this is misbranding
cGMP applies to who?
Manufacturers
Manufacturers must go through the inspection process every ____ years.
Once every 2 years
Moving a drug manufacturer facility oversees exempts a manufacturer from
cGMP.
False - cGMP applies to facilities in the US and making products for use in the US
What 3 things constitute pharmacy compounding?
1. For an individual patient
2. Based on receipt of valid Rx or drug order from licensed practitioner
3. Compounded by a licensed pharmacist or physician
If something meets criteria for pharmacy compounding, it is exempt from what 3
regulations?
cGMP
Misbranding
New drug requirements
T/F Pharmacists may compound something before the receipt of an Rx?
True
If a location does not meet requirements of pharmacy compounding, what are
they considered?
An outsourcing facility
Which medical device is the simplest device?
Class I
Medical Device Class: Stethoscope
Class I
Medical Device Class: Scissors
Class I
Medical Device Class: Toothbrushes
Class I
Medical Device Class: Syringes
Class II
Medical Device Class: Tampons
Class II
Medical Device Class: Condoms
Class II
Medical Device Class: Hgb A1c Assays
Class II
Which device class requires special controls to assure safety and effectiveness
of the device such as performance standards, postmarket surveillance, patient
registries, etc
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