MPJE Indiana exam prep 100% Verified Questions
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Terms in this set (231)
A written law enacted by the Statute
legislature
A rule having the force of law issued Regulation
by an ADMINISTRATIVE AGENCY
Where are regulations found 1. CFR (code of federal regulations)
(Federal)? Indiana? 2. IAC (Indiana administrative code)
Unsafe coloring agent or unsafe Adulteration
additive is an example of?
Directions when following are Misbranding
dangerous is an example of?
When are compounded drugs If the compound is for:
exempt from CGMP? 1. An individual patient
2. Based on the receipt of a valid prescription
3. Compounded by a licensed pharmacist or
licensed physician
,Pharmacies cannot compound and 5%
distribute more than (%) of total
prescriptions dispensed or
distributed
Simplest device type that does not Class I
present unreasonable risk of illness
or injury?
Examples of Class 1 devices? Stethoscopes, scissors and toothbrushes
Devices that require special controls Class II
to assure the safety and
effectiveness of the device?
Examples of Class II devices? Syringes, tampons, condoms, hemoglobin A1C
immunoassays
Devices that require premarket Class III
approval before marketing and are
of substantial importance in
preventing impairment of human
health or presents a potential
unreasonable risk of illness of injury?
Examples of Class III devices? Pacemakers, replacement heart valves and soft
contact lenses
All new devices automatically fall Class III
into this class unless FDA determines
that they are substantially equivalent
to other classes?
, Currently the only BANNED device? Prosthetic hair fibers
Examples of devices that require a Contact lenses and diaphragms
prescription?
FDA can require a manufacturer to False. Manufacturers can voluntarily issue a recall
recall a drug (T/F)? or can be requested by the FDA
Gives Consumer Product Safety Poison Prevention Packaging Act
Commission authority to require
special packaging of hazardous
substances?
Testing requirements that a package 1. At least 90% of adults should be able to open the
must meet to be considered child container without significant difficulty
resistant and qualify as special 2. At least 85% of children under 5 who are not
packaging? familiar with the packaging, should not be able to
open the container in five minutes
3. At least 80% of children under 5 still cannot open
the package after an adult shows them how to
open the container in five minutes
And Answers
Save
Terms in this set (231)
A written law enacted by the Statute
legislature
A rule having the force of law issued Regulation
by an ADMINISTRATIVE AGENCY
Where are regulations found 1. CFR (code of federal regulations)
(Federal)? Indiana? 2. IAC (Indiana administrative code)
Unsafe coloring agent or unsafe Adulteration
additive is an example of?
Directions when following are Misbranding
dangerous is an example of?
When are compounded drugs If the compound is for:
exempt from CGMP? 1. An individual patient
2. Based on the receipt of a valid prescription
3. Compounded by a licensed pharmacist or
licensed physician
,Pharmacies cannot compound and 5%
distribute more than (%) of total
prescriptions dispensed or
distributed
Simplest device type that does not Class I
present unreasonable risk of illness
or injury?
Examples of Class 1 devices? Stethoscopes, scissors and toothbrushes
Devices that require special controls Class II
to assure the safety and
effectiveness of the device?
Examples of Class II devices? Syringes, tampons, condoms, hemoglobin A1C
immunoassays
Devices that require premarket Class III
approval before marketing and are
of substantial importance in
preventing impairment of human
health or presents a potential
unreasonable risk of illness of injury?
Examples of Class III devices? Pacemakers, replacement heart valves and soft
contact lenses
All new devices automatically fall Class III
into this class unless FDA determines
that they are substantially equivalent
to other classes?
, Currently the only BANNED device? Prosthetic hair fibers
Examples of devices that require a Contact lenses and diaphragms
prescription?
FDA can require a manufacturer to False. Manufacturers can voluntarily issue a recall
recall a drug (T/F)? or can be requested by the FDA
Gives Consumer Product Safety Poison Prevention Packaging Act
Commission authority to require
special packaging of hazardous
substances?
Testing requirements that a package 1. At least 90% of adults should be able to open the
must meet to be considered child container without significant difficulty
resistant and qualify as special 2. At least 85% of children under 5 who are not
packaging? familiar with the packaging, should not be able to
open the container in five minutes
3. At least 80% of children under 5 still cannot open
the package after an adult shows them how to
open the container in five minutes
