Indiana MPJE Review Part 1, Indiana MPJE
Review Part 2, Indiana MPJE Review Part 3,
Indiana MPJE Review Part 4
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
Class II
Which device Class requires premarket approval?
Class III
Medical Device Class: pacemakers
Class III
Medical Device Class: replacement heart valves
Class III
Medical Device Class: Soft contact lenses
Class III
All new devices automatically fall into this class unless FDA determines that they
are substantially equivalent to other classes?
Class III
What types of devices require an Rx due to the potential harm and need for
collateral measures to ensure their proper use?
Restricted devices
What are some examples of restricted devices?
Contact lenses and diaphragms
What is currently the only banned device?
Prosthetic hair fibers
What type of devices are excluded from the US market?
Banned devices
Which of the following does the FDA NOT have the authority to mandate a recall?
A. Devices
B. Drugs
C. Foods
D. Biological products
B - Drugs - they can only be voluntarily issued by the manufacturer
What kind of action can the FDA take if they believe a drug should be recalled,
but the manufacturer is unwilling to issue the recall?
Seizure or injunction action
Who is responsible for notifying consumers of recalls?
The sellers
Who is responsible for notifying sellers about a recall?
The manufacturers
Recall Class: Missing batch # on medication bottle
Class III
Recall Class: Valsartan contains NMDA
Class I
Recall Class: microbial contamination of a personal lubricant
Class II
Recall Class: microbial contamination of non-injectable, non-ophthalmic sterile
product that can cause medical issue
, Class II
Recall Class: insecure or incorrect closures for medicines such as cytotoxics
Class II
Recall class: hardware or software failures in ventilators resulting in shut down
during its use
Class I
Recall Class: microbial contamination of sterile injectable
Class I
Recall Class: a false result on an IVD test for digoxin levels
Class I: Digoxin has a narrow therapeutic range and if overdose could cause serious
damage
Recall Class: False negative result on an IVD test for HIV
Class I
Recall Class: blood components accidently released after donation tested initial-
positive
Class I
Recall Class: infusion pumps giving visual or audible alarms due to software or
hardware issues resulting in delay in infusion
Class II
Recall Class: IVD test kit that could identify the wrong strain of micro-organism
Class II
Recall Class: the outer packaging of a medical device indicates a different size to
that which is actually in the supplied in the box, but it is obvious to the clinician it
is the incorrect size
Class III
What is the goal of the PPPA?
To prevent accidental poisoning in children under the age of 5
The PPPA gives which organization the authority to require special packaging of
"hazardous substances"?
Consumer Product Safety Commission
What are the 3 requirements for CRC packaging?
1. 90%+ adults should be able to open without difficulty
2. 85% of children < 5 who have never seen this packaging and were not given
directions should not be able to open the package in 5 min
3. At least 80% < 5 yo still cannot open the package after an adult shows them how to
open the container in 5 minutes
Which route of administration of drugs does the PPPA apply to?
Oral drugs ONLY!
T/F Prescribers and patients can issue a blanket waiver for non-child resistant
packaging for their Rxs.
F: Patients can issue a blanket waiver for their Rxs to have the easy-open caps
Providers can only issue a prescription-by-prescription waiver
Review Part 2, Indiana MPJE Review Part 3,
Indiana MPJE Review Part 4
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
Class II
Which device Class requires premarket approval?
Class III
Medical Device Class: pacemakers
Class III
Medical Device Class: replacement heart valves
Class III
Medical Device Class: Soft contact lenses
Class III
All new devices automatically fall into this class unless FDA determines that they
are substantially equivalent to other classes?
Class III
What types of devices require an Rx due to the potential harm and need for
collateral measures to ensure their proper use?
Restricted devices
What are some examples of restricted devices?
Contact lenses and diaphragms
What is currently the only banned device?
Prosthetic hair fibers
What type of devices are excluded from the US market?
Banned devices
Which of the following does the FDA NOT have the authority to mandate a recall?
A. Devices
B. Drugs
C. Foods
D. Biological products
B - Drugs - they can only be voluntarily issued by the manufacturer
What kind of action can the FDA take if they believe a drug should be recalled,
but the manufacturer is unwilling to issue the recall?
Seizure or injunction action
Who is responsible for notifying consumers of recalls?
The sellers
Who is responsible for notifying sellers about a recall?
The manufacturers
Recall Class: Missing batch # on medication bottle
Class III
Recall Class: Valsartan contains NMDA
Class I
Recall Class: microbial contamination of a personal lubricant
Class II
Recall Class: microbial contamination of non-injectable, non-ophthalmic sterile
product that can cause medical issue
, Class II
Recall Class: insecure or incorrect closures for medicines such as cytotoxics
Class II
Recall class: hardware or software failures in ventilators resulting in shut down
during its use
Class I
Recall Class: microbial contamination of sterile injectable
Class I
Recall Class: a false result on an IVD test for digoxin levels
Class I: Digoxin has a narrow therapeutic range and if overdose could cause serious
damage
Recall Class: False negative result on an IVD test for HIV
Class I
Recall Class: blood components accidently released after donation tested initial-
positive
Class I
Recall Class: infusion pumps giving visual or audible alarms due to software or
hardware issues resulting in delay in infusion
Class II
Recall Class: IVD test kit that could identify the wrong strain of micro-organism
Class II
Recall Class: the outer packaging of a medical device indicates a different size to
that which is actually in the supplied in the box, but it is obvious to the clinician it
is the incorrect size
Class III
What is the goal of the PPPA?
To prevent accidental poisoning in children under the age of 5
The PPPA gives which organization the authority to require special packaging of
"hazardous substances"?
Consumer Product Safety Commission
What are the 3 requirements for CRC packaging?
1. 90%+ adults should be able to open without difficulty
2. 85% of children < 5 who have never seen this packaging and were not given
directions should not be able to open the package in 5 min
3. At least 80% < 5 yo still cannot open the package after an adult shows them how to
open the container in 5 minutes
Which route of administration of drugs does the PPPA apply to?
Oral drugs ONLY!
T/F Prescribers and patients can issue a blanket waiver for non-child resistant
packaging for their Rxs.
F: Patients can issue a blanket waiver for their Rxs to have the easy-open caps
Providers can only issue a prescription-by-prescription waiver
