CPJE Law Review – Questions With Right Solutions
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Terms in this set (81)
What needs to be included when Patient Package Insert
dispensing a drug with estrogen is
component?
Exceptions to dispensing oral meds in SL ntg, colestipol powder, erythromycin granules for
child resistant safety containers suspension, oral contraceptives in manufacturers
package
Pharmacist CE requirements 30 hrs/2 yrs 2 hr in law and ethics 1 hr in cultural
competency and humility must retain certificates for
4 years
REMS programs that pharmacies need Clozapine, isotretinoin(Ipledge) natalizumab,
to be enrolled in zyprexxa relprevv, thalidomide (steps)
Recalls Class I: serious consequences and death
Class II: temporary or medically reversible
Class III: not likely to cause adverse health
consequences
Medical device safety alert: in some cases also
considered recalls
Timeline for notifying the board 30 days- change of ownership, address or name
changes, pharmacist in charge, pharmacy permit,
theft, diversion, drug loss including CS but need to
report to DEA immediately but if the cause is staff
use 14 days
14 days- licensed employee is found chemically
mentally or physically impaired
Immediately for bankruptcy, insolvency, or
receivership
, What to inform the board of when a Transfer of drugs notice within 10 days in writing
pharmacy is closing
Time limit requirements for record 1 year- pt medication profile and quality assurance
keeping in the pharmacy programs
2 years- pseudoephedrine sale logs
3 years- community or clinic pharmacy prescriptions,
CS inventories, pharmacy self assessment, laminar air
flow hood cert, purchase invoices, dea 222 and 106,
return of drugs to wholesaler or manufacturer,
transfer or sale to other pharmacy or MD, hospital
chart orders for non controlled, HIV prep
documentation, community pharmacy med error
reports
4 years- ce certs
6 years- HIPAA notice signed by patients
7 years- hospital pharmacy chart orders for CS
Offsite storage of prescriptions Need to have a storage waiver approval from the
board and all records must be retrievable in 48 hrs
but records must remain on site for 1 year to non cs
and 2 years for cs
Self assessment survey - every pharmacy must complete before July 1 of
every odd numbered year by PIC
- reviews pharmacy compliance with fed and state
laws
- if sterile drug compounding, need separate self-
assessment
- keep in pharmacy for 3 years
Also must be done within 30 days of a new license
issued, charge of PIC or rep in charge, change in
facilities address
Rules for PICs Can operate max of 2 pharmacies within 50 miles of
each other
Cannot be a pic and a rep in charge
Interim pics max of 120 days
Must complete boards PIC training course within 2
years prior
Save
Terms in this set (81)
What needs to be included when Patient Package Insert
dispensing a drug with estrogen is
component?
Exceptions to dispensing oral meds in SL ntg, colestipol powder, erythromycin granules for
child resistant safety containers suspension, oral contraceptives in manufacturers
package
Pharmacist CE requirements 30 hrs/2 yrs 2 hr in law and ethics 1 hr in cultural
competency and humility must retain certificates for
4 years
REMS programs that pharmacies need Clozapine, isotretinoin(Ipledge) natalizumab,
to be enrolled in zyprexxa relprevv, thalidomide (steps)
Recalls Class I: serious consequences and death
Class II: temporary or medically reversible
Class III: not likely to cause adverse health
consequences
Medical device safety alert: in some cases also
considered recalls
Timeline for notifying the board 30 days- change of ownership, address or name
changes, pharmacist in charge, pharmacy permit,
theft, diversion, drug loss including CS but need to
report to DEA immediately but if the cause is staff
use 14 days
14 days- licensed employee is found chemically
mentally or physically impaired
Immediately for bankruptcy, insolvency, or
receivership
, What to inform the board of when a Transfer of drugs notice within 10 days in writing
pharmacy is closing
Time limit requirements for record 1 year- pt medication profile and quality assurance
keeping in the pharmacy programs
2 years- pseudoephedrine sale logs
3 years- community or clinic pharmacy prescriptions,
CS inventories, pharmacy self assessment, laminar air
flow hood cert, purchase invoices, dea 222 and 106,
return of drugs to wholesaler or manufacturer,
transfer or sale to other pharmacy or MD, hospital
chart orders for non controlled, HIV prep
documentation, community pharmacy med error
reports
4 years- ce certs
6 years- HIPAA notice signed by patients
7 years- hospital pharmacy chart orders for CS
Offsite storage of prescriptions Need to have a storage waiver approval from the
board and all records must be retrievable in 48 hrs
but records must remain on site for 1 year to non cs
and 2 years for cs
Self assessment survey - every pharmacy must complete before July 1 of
every odd numbered year by PIC
- reviews pharmacy compliance with fed and state
laws
- if sterile drug compounding, need separate self-
assessment
- keep in pharmacy for 3 years
Also must be done within 30 days of a new license
issued, charge of PIC or rep in charge, change in
facilities address
Rules for PICs Can operate max of 2 pharmacies within 50 miles of
each other
Cannot be a pic and a rep in charge
Interim pics max of 120 days
Must complete boards PIC training course within 2
years prior
