WISCONSIN MPJE COMPRHENSIVE 2026 QUESTIONS AND
SOLUTIONS SCORED A+
✔✔Five Percent Rule - ✔✔The total number of dosage units of all controlled substances
distributed by a pharmacy may not exceed 5% of all controlled substances dispensed
by the pharmacy during a calendar year. (includes CS plus non-CS)
If at any time the controlled
substances distributed exceed five percent, the pharmacy is required to register as a
distributor.
✔✔CS inventory recordkeeping - ✔✔Federal: every 2 years, initial registration,
buying/selling
WI: C2 perpetual inventory, reconciled at least quarterly
✔✔CS inventory counts - exact vs estimate - ✔✔Exact count - all C2, containers of
>1000 tabs/caps (C2-C5)
Estimated - all others
✔✔CS Recordkeeping - ✔✔-Keep C2 records separate from others
Duration
-Prescriptions/med profiles - 5 years
-DEA required records - 2 years
✔✔Readily retrievable CS info - ✔✔C3-C5 records should be kept in such manner that
they are easily identifiable or accessible when needed while dispersed with other
records. (Using a red C, computer system)
✔✔How can CS be stored? - ✔✔Locked cabinet or dispersed in pharmacy
✔✔CS Significant loss - ✔✔-Consider what is a significant loss of controls, err on side
of caution
Does not include
-Clerical errors, miscounts
-Breakage, damage, spillage
Keep file of loss for future reference
✔✔Significant loss process - ✔✔1. Notify local police
2. Notify local DEA field office DIRECTLY IN WRITING within one business day (and
PEB)
3. DEA Form 106
,✔✔Requirements of health items returned to a community pharmacy - ✔✔May be
returned and re-sold
-only perfect boxed of consumer packaged OTC items pharmacist determines are in
good shape
May be returned and must be disposed of
-dispensed in error
-adulterated, misbranded, or expired
-when allowing drugs to remain in patient's possession could cause substantial harm
--No federal controlled substances are allowed to be returned to pharmacy except for
dispensing error or recall--
WI does not recognize drugs returned for destruction/disposal as a "return"
✔✔Returns to Institution/LTCF - ✔✔-may return if drug has not left control of staff
May be re-dispensed when
-item was never in possession of the patient +
-drug is in tamper-evident package with lot, BUD +
-original container, not adulterated or misbranded
Meds at LTCF must be returned for credit or destroyed with 72 hours
CS may not be returned from LTCF (destroyed instead)
✔✔CS: rendered non-retrievable - ✔✔A CS is irreversibly altered through physical or
chemical means so that it is unusable for any practical purpose
✔✔Non-Retrievable Destruction Methods - ✔✔-Incinerate
-Adsorption/sequestration - not endorsed by DEA (Dispose Rx, RxDestroyer, Cactus)
Flushing and throwing away medications are NOT non-retrievable methods
✔✔Patient CS disposal options - ✔✔-DEA take-back days
-med receptacles (pharmacies, police)
-DisposeRx and other commercial options
-coffee grounds, kitty litter, dirt
-flushing - only recommended for unused opioids to urgently keep out of circulation
✔✔Authorized Collector of CS - ✔✔Pharmacies, hospitals, LTCF, narcotic treatment
programs, manufacturers distributors
May place a collection receptacle within registered location
, Collectors cannot place anything in the receptacles
✔✔Collection receptacles (rules, disposal) - ✔✔-No C1 or sharps
-May put non-CS in but not the purpose of them
-Within view of employees
-Securely locked and fastened to permanent structure
When full, two employees must remove and seal inner liner each time. Store in secure
location until shipped.
-Two employees must witness transfer during pickup
✔✔Reverse Distributor - ✔✔DEA registrant which may receive CS and inner liners from
authorized collectors, law enforcement, and registrants
DEA Form 41 is completed when picking up
DEA Form 222 is issued by reverse distributor if a pharmacy returns C2 inventory
✔✔Mail-back programs - ✔✔Patients provided a pre-addressed, postage paid mail
package that is nondescript so people won't know
It doesn't go to a pharmacy but rather a collector that is authorized by DEA to destroy
meds
Consumers do not have to identify themselves but the boxes do have unique
identifiers....
✔✔Disposal of Pharmacy CS Inventory - ✔✔-expired or returned drugs; or recoverable
breakage/spillage
Options
-destruction on-site
-reverse distributor (Form 222)
-return or recall - ship to mfr
-request DEA assistance (Form 41)
Non-recoverable waste -> Form 41 with 2 witnesses and documentation of events
✔✔Investigational New Drug (IND) - ✔✔A request for authorization from the FDA to use
a new drug, agent, or biologic in humans before FDA review of clinical data to
determine if the product is safe and effective for an indication.
✔✔Phase 1 Clinical Trials - ✔✔-First in human, typically healthy volunteers
N= 20-80
-Tests safety and toxicity, ADME
-Open label, dose finding
SOLUTIONS SCORED A+
✔✔Five Percent Rule - ✔✔The total number of dosage units of all controlled substances
distributed by a pharmacy may not exceed 5% of all controlled substances dispensed
by the pharmacy during a calendar year. (includes CS plus non-CS)
If at any time the controlled
substances distributed exceed five percent, the pharmacy is required to register as a
distributor.
✔✔CS inventory recordkeeping - ✔✔Federal: every 2 years, initial registration,
buying/selling
WI: C2 perpetual inventory, reconciled at least quarterly
✔✔CS inventory counts - exact vs estimate - ✔✔Exact count - all C2, containers of
>1000 tabs/caps (C2-C5)
Estimated - all others
✔✔CS Recordkeeping - ✔✔-Keep C2 records separate from others
Duration
-Prescriptions/med profiles - 5 years
-DEA required records - 2 years
✔✔Readily retrievable CS info - ✔✔C3-C5 records should be kept in such manner that
they are easily identifiable or accessible when needed while dispersed with other
records. (Using a red C, computer system)
✔✔How can CS be stored? - ✔✔Locked cabinet or dispersed in pharmacy
✔✔CS Significant loss - ✔✔-Consider what is a significant loss of controls, err on side
of caution
Does not include
-Clerical errors, miscounts
-Breakage, damage, spillage
Keep file of loss for future reference
✔✔Significant loss process - ✔✔1. Notify local police
2. Notify local DEA field office DIRECTLY IN WRITING within one business day (and
PEB)
3. DEA Form 106
,✔✔Requirements of health items returned to a community pharmacy - ✔✔May be
returned and re-sold
-only perfect boxed of consumer packaged OTC items pharmacist determines are in
good shape
May be returned and must be disposed of
-dispensed in error
-adulterated, misbranded, or expired
-when allowing drugs to remain in patient's possession could cause substantial harm
--No federal controlled substances are allowed to be returned to pharmacy except for
dispensing error or recall--
WI does not recognize drugs returned for destruction/disposal as a "return"
✔✔Returns to Institution/LTCF - ✔✔-may return if drug has not left control of staff
May be re-dispensed when
-item was never in possession of the patient +
-drug is in tamper-evident package with lot, BUD +
-original container, not adulterated or misbranded
Meds at LTCF must be returned for credit or destroyed with 72 hours
CS may not be returned from LTCF (destroyed instead)
✔✔CS: rendered non-retrievable - ✔✔A CS is irreversibly altered through physical or
chemical means so that it is unusable for any practical purpose
✔✔Non-Retrievable Destruction Methods - ✔✔-Incinerate
-Adsorption/sequestration - not endorsed by DEA (Dispose Rx, RxDestroyer, Cactus)
Flushing and throwing away medications are NOT non-retrievable methods
✔✔Patient CS disposal options - ✔✔-DEA take-back days
-med receptacles (pharmacies, police)
-DisposeRx and other commercial options
-coffee grounds, kitty litter, dirt
-flushing - only recommended for unused opioids to urgently keep out of circulation
✔✔Authorized Collector of CS - ✔✔Pharmacies, hospitals, LTCF, narcotic treatment
programs, manufacturers distributors
May place a collection receptacle within registered location
, Collectors cannot place anything in the receptacles
✔✔Collection receptacles (rules, disposal) - ✔✔-No C1 or sharps
-May put non-CS in but not the purpose of them
-Within view of employees
-Securely locked and fastened to permanent structure
When full, two employees must remove and seal inner liner each time. Store in secure
location until shipped.
-Two employees must witness transfer during pickup
✔✔Reverse Distributor - ✔✔DEA registrant which may receive CS and inner liners from
authorized collectors, law enforcement, and registrants
DEA Form 41 is completed when picking up
DEA Form 222 is issued by reverse distributor if a pharmacy returns C2 inventory
✔✔Mail-back programs - ✔✔Patients provided a pre-addressed, postage paid mail
package that is nondescript so people won't know
It doesn't go to a pharmacy but rather a collector that is authorized by DEA to destroy
meds
Consumers do not have to identify themselves but the boxes do have unique
identifiers....
✔✔Disposal of Pharmacy CS Inventory - ✔✔-expired or returned drugs; or recoverable
breakage/spillage
Options
-destruction on-site
-reverse distributor (Form 222)
-return or recall - ship to mfr
-request DEA assistance (Form 41)
Non-recoverable waste -> Form 41 with 2 witnesses and documentation of events
✔✔Investigational New Drug (IND) - ✔✔A request for authorization from the FDA to use
a new drug, agent, or biologic in humans before FDA review of clinical data to
determine if the product is safe and effective for an indication.
✔✔Phase 1 Clinical Trials - ✔✔-First in human, typically healthy volunteers
N= 20-80
-Tests safety and toxicity, ADME
-Open label, dose finding
