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
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
