MPJE Indiana Flashcards
How many board members?
7
how many board members are pharmacists?
6
1 must be hospital
who appointments board members
governor
how long do board members serve?
4 years
how many times/year do board members convene
8 x
who can attend board meetings?
anyone
How many CE hours are needed for renewal
30 hours every 2 years (even numbers)
CE requirements
max 1/5th of hours in business, management, computers
4/5th must be practice realated
half of hours must be acpe approved
renewal period - pharm license and tech license
June 30th on even numbered years
required hours for pharmaicst license
1500
how much rxs be stored
for 2 years in one of the following:
3 files: Cii, Ciii-v, legend
2 files: noncontrolled and controlled (must have red C stamp)
2 file: CII, all others with red C on ciii-v
do hard copies have to be stored on site?
no, but must be accessible for BOP
time period to notify board of changes of ownership of pharmacy
10 days
time period to notify board of changes to PIC
immediately
time period to notify board of change of address
no timeline, must file with application
time period to notify board of change of hours
no times - must be submitted in writing
how long of closure requires board notification?
5 or more consecutive days
Required equipment
sink with hot and cold water, power sewage outlet, refrigeration
emergency access to pharmacy
supervisor licensed nurse once per shift may access pharmacy if drugs not available in dispensing cabinets. Must be documented and copy of order left
What is adulteration?
An issue is with the product itself
Must err on the side of caution and assume it’s adulterated if the product has been put in a compromising position
What is misbranding?
There is an issue with the words associated with the product
Ex: prescription label requirements are not met
What is cGMP
Current good manufacturing practices
Set minimum requirements for manufacturing of drugs
Do’s and Donts of Compounding
Must be: for an individual patient, with a prescription, but can compound it before receiving the Rx based on prescribing history
Can not be a commercially available product
Does not including reconstituting, mixing, or other instructions on approved labeling
What must be included on an Rx label for an outsourced compounded product?
“This is a compounded drug” Outsourcing facility info Batch number Expiration date Storage instructions List of active ingredients
A pharmacist forgets to dispense a med guide with sertraline. What is this considered?
Misbranding
What class medical device are contact lenses?
Class III - most complicated class as mistakes can cause vision loss
Which drug recall is the most severe?
One
This can cause death, things like wrong drug in bottle
Can the FDA force a recall?
No, they must be voluntary
What is the PPPA
Poison Prevention Packaging Act
Enacted to prevent accidental poisoning in children under 5
What are some CRC exempt products?
Nitro stat, Medrol dose pack, birth control
Reusing a plastic vial is totally okay according to the PPPA
No! Must replace any plastic parts, glass or metal are okay to reuse though
Which DEA form is used for ordering and transferring C-II?
222