Nebraska Pharmacy Law Exam
Questions and Complete Solutions
Graded A+
Reasons a pharmacy can take back dispensed medications? - Answer: -for disposal only
-in response to a recall, for disposal only
-from a LTCF, for credit or for relabeling and redispensing
**No CS**
Returns for credit, relabeling, and redispensing from LTCF requirements: - Answer: -No CS
-No compounded meds
-must have been in control of LTCF at all times
-in original, unopened, labeled container w/ tamper-evident seal intact
-container must have exp. date and lot # (as defined from manuf. or packager)
-max of 14 d/s
-only intact tabs and caps
Cancer Drug Repository Program - Answer: Program for accepting donated cancer drugs and dispensing
such drugs to NE residents
-a prescription drug (of any administration route) used to treat cancer or its side effects
-in original, unopened packaging
-NOT expired
-room temp. drugs only
-NO CS
Participant registry w/ participant's names, address, and telephone #
Must maintain perpetual inventory logbook
,Hard copy must be maintained by dispenser for 5 years
Immunosuppressant Drug Repository Program - Answer: Program for accepting donated
immunosuppressant drugs to program participants
Similar to Cancer drug repository program; but no participant registry
Controlled Substances (CII-V) Storage - Answer: 1) in a locked cabinet; or
2) distributed throughout the inventory of non-controlled substances
CI must be kept in a locked cabinet
CS Disposal- Owner is registrant - Answer: CII-V may be destroyed by:
-pharmacy inspector
-reverse distributor
-federal DEA
Complete records of destruction must be kept for 5 years
CS Disposal- Owner is patient or resident of LTCF or hospital - Answer: Owner may transfer CS to
pharmacy for immediate destruction by 2 individuals credentialed under the UCA & designated by the
pharmacy, LTCF, or hospital
Requirements for closing a pharmacy (terminating business) - Answer: Tell department w/in 15 days
Notify patients and tell them where their records will be; send proof of notice to department
DEA form 41 - Answer: Reverse distributor responsible for filling out
Destruction of CS by sending to reverse distributor
, Significant theft or loss of CS - Answer: Notify DEA in writing w/in 24 hrs
Notify local police
Notify state inspector
DEA for 106 - Answer: Significant theft or loss of CS
Document circumstances and quantities
1 copy to DHHS (division of investigation)
1 copy to State Trooper Commander
Keep 1 copy for records
What to do if found that there was no significant theft or loss after DEA notified? - Answer: No need to
fill out DEA form 106
Notify DEA in writing as to why the issue was resolved
CS inventory requirements - Answer: Annually; sent copies to State w/in 30 days (NOT to feds)
-separate CIIs from CIII-V
-date, time of day, signature of person who completed inventory
-EXACT counts of all CS
-does not have to pharmacist by law
Keep inventories x 5 years
{Fed: Biennial; exact count of CII; may estimate CIII-V if in bottles <1,000}
Questions and Complete Solutions
Graded A+
Reasons a pharmacy can take back dispensed medications? - Answer: -for disposal only
-in response to a recall, for disposal only
-from a LTCF, for credit or for relabeling and redispensing
**No CS**
Returns for credit, relabeling, and redispensing from LTCF requirements: - Answer: -No CS
-No compounded meds
-must have been in control of LTCF at all times
-in original, unopened, labeled container w/ tamper-evident seal intact
-container must have exp. date and lot # (as defined from manuf. or packager)
-max of 14 d/s
-only intact tabs and caps
Cancer Drug Repository Program - Answer: Program for accepting donated cancer drugs and dispensing
such drugs to NE residents
-a prescription drug (of any administration route) used to treat cancer or its side effects
-in original, unopened packaging
-NOT expired
-room temp. drugs only
-NO CS
Participant registry w/ participant's names, address, and telephone #
Must maintain perpetual inventory logbook
,Hard copy must be maintained by dispenser for 5 years
Immunosuppressant Drug Repository Program - Answer: Program for accepting donated
immunosuppressant drugs to program participants
Similar to Cancer drug repository program; but no participant registry
Controlled Substances (CII-V) Storage - Answer: 1) in a locked cabinet; or
2) distributed throughout the inventory of non-controlled substances
CI must be kept in a locked cabinet
CS Disposal- Owner is registrant - Answer: CII-V may be destroyed by:
-pharmacy inspector
-reverse distributor
-federal DEA
Complete records of destruction must be kept for 5 years
CS Disposal- Owner is patient or resident of LTCF or hospital - Answer: Owner may transfer CS to
pharmacy for immediate destruction by 2 individuals credentialed under the UCA & designated by the
pharmacy, LTCF, or hospital
Requirements for closing a pharmacy (terminating business) - Answer: Tell department w/in 15 days
Notify patients and tell them where their records will be; send proof of notice to department
DEA form 41 - Answer: Reverse distributor responsible for filling out
Destruction of CS by sending to reverse distributor
, Significant theft or loss of CS - Answer: Notify DEA in writing w/in 24 hrs
Notify local police
Notify state inspector
DEA for 106 - Answer: Significant theft or loss of CS
Document circumstances and quantities
1 copy to DHHS (division of investigation)
1 copy to State Trooper Commander
Keep 1 copy for records
What to do if found that there was no significant theft or loss after DEA notified? - Answer: No need to
fill out DEA form 106
Notify DEA in writing as to why the issue was resolved
CS inventory requirements - Answer: Annually; sent copies to State w/in 30 days (NOT to feds)
-separate CIIs from CIII-V
-date, time of day, signature of person who completed inventory
-EXACT counts of all CS
-does not have to pharmacist by law
Keep inventories x 5 years
{Fed: Biennial; exact count of CII; may estimate CIII-V if in bottles <1,000}