CPJEg2024g(AllgCorrectg100%)
PoisongPreventiongPackaginggAct-gplacegORALg(only)gRxgmedsgingchild-
resistantgsafetygcontainers.gWhatgaregthegexceptions?g-gAnswer-g-gNitroglyceringSLgtab
- Erythromycingethylsuccinateggranulesgforgoralgsuspension
- colestipolgpowderg(Colestid-gBAS)
- oralgcontraceptivesgingmanufacturer'sgmemory-aidgdispensergpackages
- Doctorgorgpatientgmaygrequestgagnon-complyinggcontainerg(keepgdocumentationgifgthatgoccurs)
erythromycingoralgcounselingg-gAnswer-
gBase,gPCEgorgstearategdosagegformsgshouldgbegtakengongangemptygstomach
Ethylsuccinateg(E.E.S.gGranules)gorgdelayed-releaseg(Ery-Tab)gadmingwithoutgregardgtogmeals--
>gMaygconsidergadministeringgaftergfoodgtogdecreasegGIgdiscomfort.
DEAgFormg222g-gAnswer-gOrderinggofgSchedulegIg&gIIgC.SgrequiresgDEAgFormg222
- keepgrecordgforg3gYEARs
- PharmaciesgcangsellgtogothergpharmaciesgorgtogprescribersgwithgDEAg222gformg(CgIg&gII)g--
>gcangsellgMAXg5%gofgtheirgC.Sgdispensing
(ie.gcangsellg1,000gtoganothergpharmacygifgdispenseg20,000gC.Subs)
- Validgforgupgtog60gdays
- ThegreversegdistributorgissuesgDEAgFormg222gforgC.S.gII.
TransfergofgSchedulegIIgC.Sg-gAnswer-
gSchedulegIIgC.SgcanNOTgbegtransferredg(DEAgFormg222gisgNOTgusedgtogtransfergprescriptions)
Filinggofgprescriptionsg-gAnswer-gSchedulegIII,gIV,gorgVgC.SgprescriptionsgREQUIREgag1-
inchgredg'C'gonglowergrightgcornergifgfiledgalonggwithgNON-scheduledgprescriptions
- doesgnotgapplygforgelectronicgfilinggsystems
- EXCEPTION:gSchedulegIIgC.SgprescriptionsgMUSTgbegfiledgseparately
,PapergorgelectronicgC.Sgprescriptiongrecordsgmustgbegkeptgfor:g-gAnswer-g-gFederal:g2gyears
- CA:g3gyears
- Whengthere'sgagconflictgbetweengagfederalgandgagstategstatute,gthegfederalgstatutegoutweighsgthegsta
tegstatutegorgregulation,gunlessgthegstateglawgisgmoregstringentgand,gthus,gmandatesgovergtheglessgstri
ngentgfederalgrule.
RefillgPRNg(non-scheduledgdrugs)g-gAnswer-gvalidgforg1gyeargfromgthegdategprescriptiongwasgwritten
CAgContinuinggEducationgRequirementsg-gAnswer-g-g30ghoursgCE/2gyears
- 2gofgtheg30gCEghoursgMUSTgbeglawg&gethicsgfromgagcoursegprovidedgbygthegBoard
- retaingCEgcertificatesgforg4gyears
REMSg(RiskgEvaluationgandgMitigationgStrategies)g-gAnswer-g-grequiredgbygthegFDAgforgsomegdrugs
- developedgbygmanufacturergandgapprovedgbygFDAgtogensuregbenefitsgoutweighgrisks,gensuregappropria
tegprescribinggandgminimizegpatientgrisk
Recalls,gMarketgWithdrawals,g&gSafetygAlertsg-gAnswer-
gRecall:gremovegagproductgfromgmarketgbygagfirm'sgownginitiative,gFDAgrequest/order
- ClassgIgrecall:greasonablegprobabilitygofgseriousgadverseghealthgconsequences/death
- ClassgII:gmaygcausegtemporary/reversiblegS.E;gprobabilitygofgseriousgconsequencegisgremote
- ClassgIII:gnotglikelygtogcausegadverseghealthgconsequences
- Marketgwithdrawal:gfirmgremovesgthegproductgfromgmarketgand/orgcorrectsgminorgviolation
- Medicalgdevicegsafetygalert:gunreasonablegriskgofgsubstantialgharmg(ingsomegcases,gthesegsituationsgal
sogconsideredgrecall)
Boardgmustgbegnotifiedgwithin...g-gAnswer-g-
g30gdays:gchangegofgownership,gaddressgorgname/PIC/pharmacygpermit,gtheft/diversion/druggloss
- 14gdays:glicensedgemployeegisgfoundgchemically/mentally/physicallygimpaired
- Controlledgsubstances:glossesgmustgbegreportedgtogthegBoardgnoglatergthang30gdaysg(notifygD
EAgimmediately)g-->gifgthegcausegisgtheft,gdiversiongorgself-
use,glossgmustgbegreportedgwithing14gdays
,- Immediately:gbankruptcy/insolvency/receivership
Transfergofgdrugsgnoticeg-gAnswer-
gupongclosuregofgagpharmacy,gnoticegmustgbegprovidedgtogthegBoardgwithing10gdaysg(ingwriting)
- 'Closed-
Down'gpharmacy=gpharmacygnoglongergengagedgingordinarygactivitygforgatgleastg1gday/weekgduring
ganyg120gdaygperiod
- Boardgmaygissuegagtemporarygpermitgforg180gdaysgduringgagtransfergofgownershipgingordergforgt
hatgpharmacygtogcontinuegitsgoperations
TimegLimitgRequirementsgingKeepinggofgPharmacygRecords:g1-yearg-gAnswer-g-gptgmedicationgprofile
- ptgmedicationgerror
- qualitygassurancegprograms
- patientsgconsentgtogenrollgingautomaticgrefillgprogram
TimegLimitgRequirementsgingKeepinggofgPharmacygRecords:g2-yearsg-gAnswer-g-
gephedrine,gpseudoephedrineg&gphenylpropanolaminegsaleglogs
TimegLimitgRequirementsgingKeepinggofgPharmacygRecords:g3-yearsg-gAnswer-g-
gCommunity/clinicgpharmacygprescriptions
- U.SgOfficialgOrdergFormsg(DEAgFormg222)
- C.Sginventories
- theftgandglossesgreportsg(DEAgFormg106)
- Pharmacygself-assessments
- returngofgdrugsgtogwholesalergorgmanufacturer
- laminargairgflowghoodsgcertification
- transfergorgsalesgtogothergpharmaciesgandgMDs
- purchaseginvoices
- hospitalgpharmacygchartgordergrecordsgforgnon-controlledgdrugs
TimegLimitgRequirementsgingKeepinggofgPharmacygRecords:g4-yearsg-gAnswer-gC.Egcertificates
, TimegLimitgRequirementsgingKeepinggofgPharmacygRecords:g6-yearsg-gAnswer-
gHIPAAgNoticegRecordsgsignedgbygthegpatients
TimegLimitgRequirementsgingKeepinggofgPharmacygRecords:g7-yearsg-gAnswer-
gHospitalgpharmacygchartgordergrecordsgforgCONTROLLEDgsubstances
Off-sitegStoragegwaiverg-gAnswer-g-grecordsgforgnon-
controlledgsubsgmustgbegkeptgingthegpharmacygforgatgleastg1gyearg&gminimumg2gyearsgifgCS
- agpharmacygthatgwishesgtogstoregprescriptiongrecordsgoff-
sitegaftergthesegtimeglimits,gmustghavegagWAIVERgAPPROVALgfromgthegBoardgandgrecordsgmustgbegre
trievablegwithing48ghoursg(2gbusinessgdays)
AutomaticgRefillgProgramg-gAnswer-g-
gptgmaygenrollgbygwritten,gonline,gorgelectronicginformedgconsentgtogparticipategforgea/newgRxgwhereingt
heregisgagchangegingmed,gstrength,gdosagegformgorgdirectionsgforguse
- keepgpatient'sgconsentgtogenrollgforg1gyear
- annualgrenewalg+gdruggregimengreviewgatgthegtimegofgrefillg+gnotificationg(forgea/refill)gtogthegpatientgt
hatgRxgisgbeinggrefilledgviagprogram
Pharmacygself-assessmentgsurveyg-gAnswer-g-
gpharmacies,gcompoundinggpharmaciesgandgwholesalersgmustgcompletegself-
assessmentsgbygJulyg1stgofgeachgodd-numberedgyear
- completedgassessmentsgkeptg@gfacilitygforg3gyears
- submittedgtogthegBoardgONLYgifgrequested
- ALSO,gnewgself-assessmentgformsgmustgbegcompletedgWITHINg30-daysgwhenever:
a) newglicensegisgissued
b) changegingPICgorgdesignatedgrepresentative-in-charge
c) changegingfacilitygaddress
Pharmacist-In-Chargeg(PIC)g-gAnswer-g-
goperatesg2gpharmaciesgMAXg(mustgbegwithing50gmilesgofgoneganother)
- respondsgtogthegpharmacygself-assessmentgsurveys
- canNOTgservegconcurrentlygasgPICgandg'exemptee-in-charge'gorg'representative-in-
charge'gforgagwholesalergorgveterinarygfood-animalgdruggretailer
- InterimgPICsgcangonlygbegdesignatedgforgMAXg120gdays
PoisongPreventiongPackaginggAct-gplacegORALg(only)gRxgmedsgingchild-
resistantgsafetygcontainers.gWhatgaregthegexceptions?g-gAnswer-g-gNitroglyceringSLgtab
- Erythromycingethylsuccinateggranulesgforgoralgsuspension
- colestipolgpowderg(Colestid-gBAS)
- oralgcontraceptivesgingmanufacturer'sgmemory-aidgdispensergpackages
- Doctorgorgpatientgmaygrequestgagnon-complyinggcontainerg(keepgdocumentationgifgthatgoccurs)
erythromycingoralgcounselingg-gAnswer-
gBase,gPCEgorgstearategdosagegformsgshouldgbegtakengongangemptygstomach
Ethylsuccinateg(E.E.S.gGranules)gorgdelayed-releaseg(Ery-Tab)gadmingwithoutgregardgtogmeals--
>gMaygconsidergadministeringgaftergfoodgtogdecreasegGIgdiscomfort.
DEAgFormg222g-gAnswer-gOrderinggofgSchedulegIg&gIIgC.SgrequiresgDEAgFormg222
- keepgrecordgforg3gYEARs
- PharmaciesgcangsellgtogothergpharmaciesgorgtogprescribersgwithgDEAg222gformg(CgIg&gII)g--
>gcangsellgMAXg5%gofgtheirgC.Sgdispensing
(ie.gcangsellg1,000gtoganothergpharmacygifgdispenseg20,000gC.Subs)
- Validgforgupgtog60gdays
- ThegreversegdistributorgissuesgDEAgFormg222gforgC.S.gII.
TransfergofgSchedulegIIgC.Sg-gAnswer-
gSchedulegIIgC.SgcanNOTgbegtransferredg(DEAgFormg222gisgNOTgusedgtogtransfergprescriptions)
Filinggofgprescriptionsg-gAnswer-gSchedulegIII,gIV,gorgVgC.SgprescriptionsgREQUIREgag1-
inchgredg'C'gonglowergrightgcornergifgfiledgalonggwithgNON-scheduledgprescriptions
- doesgnotgapplygforgelectronicgfilinggsystems
- EXCEPTION:gSchedulegIIgC.SgprescriptionsgMUSTgbegfiledgseparately
,PapergorgelectronicgC.Sgprescriptiongrecordsgmustgbegkeptgfor:g-gAnswer-g-gFederal:g2gyears
- CA:g3gyears
- Whengthere'sgagconflictgbetweengagfederalgandgagstategstatute,gthegfederalgstatutegoutweighsgthegsta
tegstatutegorgregulation,gunlessgthegstateglawgisgmoregstringentgand,gthus,gmandatesgovergtheglessgstri
ngentgfederalgrule.
RefillgPRNg(non-scheduledgdrugs)g-gAnswer-gvalidgforg1gyeargfromgthegdategprescriptiongwasgwritten
CAgContinuinggEducationgRequirementsg-gAnswer-g-g30ghoursgCE/2gyears
- 2gofgtheg30gCEghoursgMUSTgbeglawg&gethicsgfromgagcoursegprovidedgbygthegBoard
- retaingCEgcertificatesgforg4gyears
REMSg(RiskgEvaluationgandgMitigationgStrategies)g-gAnswer-g-grequiredgbygthegFDAgforgsomegdrugs
- developedgbygmanufacturergandgapprovedgbygFDAgtogensuregbenefitsgoutweighgrisks,gensuregappropria
tegprescribinggandgminimizegpatientgrisk
Recalls,gMarketgWithdrawals,g&gSafetygAlertsg-gAnswer-
gRecall:gremovegagproductgfromgmarketgbygagfirm'sgownginitiative,gFDAgrequest/order
- ClassgIgrecall:greasonablegprobabilitygofgseriousgadverseghealthgconsequences/death
- ClassgII:gmaygcausegtemporary/reversiblegS.E;gprobabilitygofgseriousgconsequencegisgremote
- ClassgIII:gnotglikelygtogcausegadverseghealthgconsequences
- Marketgwithdrawal:gfirmgremovesgthegproductgfromgmarketgand/orgcorrectsgminorgviolation
- Medicalgdevicegsafetygalert:gunreasonablegriskgofgsubstantialgharmg(ingsomegcases,gthesegsituationsgal
sogconsideredgrecall)
Boardgmustgbegnotifiedgwithin...g-gAnswer-g-
g30gdays:gchangegofgownership,gaddressgorgname/PIC/pharmacygpermit,gtheft/diversion/druggloss
- 14gdays:glicensedgemployeegisgfoundgchemically/mentally/physicallygimpaired
- Controlledgsubstances:glossesgmustgbegreportedgtogthegBoardgnoglatergthang30gdaysg(notifygD
EAgimmediately)g-->gifgthegcausegisgtheft,gdiversiongorgself-
use,glossgmustgbegreportedgwithing14gdays
,- Immediately:gbankruptcy/insolvency/receivership
Transfergofgdrugsgnoticeg-gAnswer-
gupongclosuregofgagpharmacy,gnoticegmustgbegprovidedgtogthegBoardgwithing10gdaysg(ingwriting)
- 'Closed-
Down'gpharmacy=gpharmacygnoglongergengagedgingordinarygactivitygforgatgleastg1gday/weekgduring
ganyg120gdaygperiod
- Boardgmaygissuegagtemporarygpermitgforg180gdaysgduringgagtransfergofgownershipgingordergforgt
hatgpharmacygtogcontinuegitsgoperations
TimegLimitgRequirementsgingKeepinggofgPharmacygRecords:g1-yearg-gAnswer-g-gptgmedicationgprofile
- ptgmedicationgerror
- qualitygassurancegprograms
- patientsgconsentgtogenrollgingautomaticgrefillgprogram
TimegLimitgRequirementsgingKeepinggofgPharmacygRecords:g2-yearsg-gAnswer-g-
gephedrine,gpseudoephedrineg&gphenylpropanolaminegsaleglogs
TimegLimitgRequirementsgingKeepinggofgPharmacygRecords:g3-yearsg-gAnswer-g-
gCommunity/clinicgpharmacygprescriptions
- U.SgOfficialgOrdergFormsg(DEAgFormg222)
- C.Sginventories
- theftgandglossesgreportsg(DEAgFormg106)
- Pharmacygself-assessments
- returngofgdrugsgtogwholesalergorgmanufacturer
- laminargairgflowghoodsgcertification
- transfergorgsalesgtogothergpharmaciesgandgMDs
- purchaseginvoices
- hospitalgpharmacygchartgordergrecordsgforgnon-controlledgdrugs
TimegLimitgRequirementsgingKeepinggofgPharmacygRecords:g4-yearsg-gAnswer-gC.Egcertificates
, TimegLimitgRequirementsgingKeepinggofgPharmacygRecords:g6-yearsg-gAnswer-
gHIPAAgNoticegRecordsgsignedgbygthegpatients
TimegLimitgRequirementsgingKeepinggofgPharmacygRecords:g7-yearsg-gAnswer-
gHospitalgpharmacygchartgordergrecordsgforgCONTROLLEDgsubstances
Off-sitegStoragegwaiverg-gAnswer-g-grecordsgforgnon-
controlledgsubsgmustgbegkeptgingthegpharmacygforgatgleastg1gyearg&gminimumg2gyearsgifgCS
- agpharmacygthatgwishesgtogstoregprescriptiongrecordsgoff-
sitegaftergthesegtimeglimits,gmustghavegagWAIVERgAPPROVALgfromgthegBoardgandgrecordsgmustgbegre
trievablegwithing48ghoursg(2gbusinessgdays)
AutomaticgRefillgProgramg-gAnswer-g-
gptgmaygenrollgbygwritten,gonline,gorgelectronicginformedgconsentgtogparticipategforgea/newgRxgwhereingt
heregisgagchangegingmed,gstrength,gdosagegformgorgdirectionsgforguse
- keepgpatient'sgconsentgtogenrollgforg1gyear
- annualgrenewalg+gdruggregimengreviewgatgthegtimegofgrefillg+gnotificationg(forgea/refill)gtogthegpatientgt
hatgRxgisgbeinggrefilledgviagprogram
Pharmacygself-assessmentgsurveyg-gAnswer-g-
gpharmacies,gcompoundinggpharmaciesgandgwholesalersgmustgcompletegself-
assessmentsgbygJulyg1stgofgeachgodd-numberedgyear
- completedgassessmentsgkeptg@gfacilitygforg3gyears
- submittedgtogthegBoardgONLYgifgrequested
- ALSO,gnewgself-assessmentgformsgmustgbegcompletedgWITHINg30-daysgwhenever:
a) newglicensegisgissued
b) changegingPICgorgdesignatedgrepresentative-in-charge
c) changegingfacilitygaddress
Pharmacist-In-Chargeg(PIC)g-gAnswer-g-
goperatesg2gpharmaciesgMAXg(mustgbegwithing50gmilesgofgoneganother)
- respondsgtogthegpharmacygself-assessmentgsurveys
- canNOTgservegconcurrentlygasgPICgandg'exemptee-in-charge'gorg'representative-in-
charge'gforgagwholesalergorgveterinarygfood-animalgdruggretailer
- InterimgPICsgcangonlygbegdesignatedgforgMAXg120gdays
