F.S. 2017 PHARMACY Ch. 465 CHAPTER 465 …

1 ; ; ;requirements; ; ;application,renewal,fees;responsibiliti es; ;application,renewal, ; ; ; ;generalrequirements; ; ,hospices, ; medicinaldrugs;display; ; sorderformedicinaldrugs;dispensingproced ure; ; Thischaptershallbeknownasthe FloridaPharmacyAct. History. , 7, ; , 3, ; ,27, ;s. 59, ;s. 6, ;s. 4, ;intent. TheLegis-laturefindsthatthepracticeofpha rmacyis a is thelegislativeintentthatpharmacistswhofa llbelowminimumcompetencyor whootherwisepresenta dangerto thepublicshallbeprohibitedfrompracticing in , 7, ; , 3, ; , 26,27, ; , ;s. 6, ;s. 4, Asusedin thischapter,theterm:(1) Administration meanstheobtainingandgivingofasingledoseo fmedicinaldrugsbyalegallyauthorizedperso ntoa patientforherorhisconsump-tion.(2) Board meanstheBoardofPharmacy.(3) Consultantpharmacist meansapharmacistlicensedbythedepartmenta ndcertifiedasa consultantpharmacistpursuanttos. (4) Datacommunicationdevice meansanelec-tronicdevicethatreceiveselec tronicinformationfromonesourceandtransmi tsorroutesittoanother,including,butnotli mitedto,anysuchbridge,router,switch,orga teway.

2 (5) Department meanstheDepartmentofHealth.(6) Dispense meansthetransferofpossessionofoneormored osesof a medicinaldrugbya dispensing,thepharmacistshall,priorto theactualphysicaltransfer,interpretandas sesstheprescriptionorderforpotentialadve rsereactions,inter-actions,anddosageregi mensheorhedeemsappro-priateintheexercise ofherorhisprofessionaljudg-ment,andtheph armacistshallcertifythatthemedicinaldrug calledforbytheprescriptionis ,eitherorallyor in writing,if in theexerciseofherorhisprofessionaljudgmen tcounselingis (7) Institutionalformularysystem meansa methodwherebythemedicalstaffevaluates,ap praises,andselectsthosemedicinaldrugsorp roprietaryprepara-tionswhichinthemedical staff sclinicaljudgmentaremostusefulin patientcare,andwhichareavailablefordispe nsingbya practicingpharmacistina ClassIIinstitutionalpharmacy.(8) Medicinaldrugs or drugs meansthosesub-stancesorpreparationscommo nlyknownas prescrip-tion or legend drugswhicharerequiredbyfederalorstatelaw tobedispensedonlyona prescription,butshallnotincludepatentsor proprietarypreparationsashereafterdefine d.

3 (9) Patentorproprietarypreparation meansamedicineinitsunbroken,originalpack agewhichissoldtothepublicby,orundertheau thorityof,themanufacturerorprimarydistri butorthereofandwhichisnotmisbrandedunder theprovisionsof theFloridaDrugandCosmeticAct.(10) Pharmacist meansanypersonlicensedpur-suanttothischa ptertopracticetheprofessionofpharmacy.(1 1)(a) PHARMACY includesa communitypharmacy,aninstitutionalpharmac y,anuclearpharmacy,aspecialpharmacy, communitypharmacy includeseverylocationwheremedicinaldrugs arecompounded,dis-pensed,stored, institutionalpharmacy includeseverylocationin a hospital,clinic,nursinghome,dispensary,s anitarium,extendedcarefacility,orotherfa cility,hereinafterreferredtoas healthcareinstitutions, wheremedicinaldrugsarecompounded,dispens ed,stored, nuclearpharmacy includeseverylocationwhereradioactivedru gsandchemicalswithintheclassificationofm edicinaldrugsarecompounded,dispensed,sto red, nuclearphar-macy specialpharmacy includeseverylocationwheremedicinaldrugs arecompounded,dis-pensed,stored,orsoldif suchlocationsarenototherwisedefinedin Internetpharmacy includeslocationsnototherwiselicensedori ssueda permitunderthischapter,withinoroutsideth isstate.

4 WhichusetheInternetto communicatewithorobtaininformationfromco nsumersin thisstateandusesuchcommunicationorinform ationtofillorrefillprescriptionsortodisp ense,distribute, subsection(13).(b)Thepharmacydepartmento f anypermitteeshallbeconsideredclosedwhene veraFloridalicensedpharmacistis notpresentandonduty shallnotbeconstruedto preventapharmacistfromexitingtheprescrip tiondepartmentforthepurposesof consultingorrespondingto inquiriesorprovidingassistanceto patientsor customers,attendingtopersonalhygieneneed s,orperforminganyotherfunctionforwhichth epharmacistisresponsible,providedthatsuc hactivitiesareconductedin a mannerconsistentwiththepharmacist sresponsibilitytopro-videpharmacyservice s.(12) Pharmacyintern meansapersonwhoiscurrentlyregisteredin,a ndattending,a dulyaccreditedcollegeorschoolofpharmacy, orwhois a graduateofsucha schoolorcollegeofpharmacy,andwhois dulyandproperlyregisteredwiththedepartme ntasprovidedforunderitsrules.

5 (13) Practiceoftheprofessionofpharmacy in-cludescompounding,dispensing,andconsu ltingcon-cerningcontents,therapeuticvalu es,andusesofanymedicinaldrug;consultingc oncerningtherapeuticva-luesandinteractio nsofpatentorproprietaryprepara-tions,whe therpursuanttoprescriptionsorintheabsenc eandentirelyindependentof suchprescriptionsororders; , otherpharmaceuticalservices meansthemonitoringofthepatient sdrugtherapyandassistingthepatientin themanagementofhisorherdrugtherapy,andin cludesreviewofthepatient sdrugtherapyandcommunicationwiththepatie nt sprescribinghealthcareprovideraslicensed underchapter458,chapter459,chapter461,or chapter466,or similarstatutoryprovisionin anotherjurisdiction,orsuchprovider sagentorsuchotherpersonsasspecificallyau thorizedbythepatient, ,nothinginthissubsectionmaybeinterpreted topermitanalterationofaprescriber sdirections,thediagnosisortreatmentofany disease,theinitiationofanydrugtherapy,th epracticeofmedicine,orthepracticeofosteo pathicmedicine,unlessotherwisepermittedb ylaw.

6 Practiceoftheprofessionofpharmacy alsoincludesanyotheract,service,operatio n,research,ortransactionincidentalto,orf orminga partof,anyoftheforegoingacts,requiring,i nvolving,oremployingthescienceorartofany branchofthepharmaceuticalprofession,stud y,ortraining,andshallexpresslypermita pharmacisttotransmitinformationfromperso nsauthorizedtopre-scribemedicinaldrugsto (14) Prescription includesanyorderfordrugsormedicinalsuppl ieswrittenortransmittedbyanymeansofcommu nicationbyadulylicensedpractitionerautho rizedbythelawsofthestatetoprescribesuchd rugsormedicinalsuppliesandintendedtobedi s-pensedbya jurisdictionotherthanthisstate,butonlyif thepharmacistcalledupontodispensesuchord erdetermines,intheexerciseofherorhisprof essionaljudgment,thattheorderis validandnecessaryforthetreatmentofa prescription alsoincludesa pharmacist berecordedin a dataprocessingsystem,providedthatsuchord ercanbeproducedin printedformuponlawfulrequest.

7 (15) Nuclearpharmacist meansapharmacistli-censedbythedepartment andcertifiedasa nuclearpharmacistpursuanttos. (16) Centralizedprescriptionfilling meansthefillingofa ,therapeuticdrugutilizationre-view,claim sadjudication,andtheobtainingofrefillaut horizations.(17) Automatedpharmacysystem meansa me-chanicalsystemthatdeliversprescriptio ndrugsre-ceivedfroma Floridalicensedpharmacyandmaintainsrelat edtransactioninformation.(18) Compounding meanscombining,mixing,oralteringtheingre dientsof oneor moredrugsor productstocreateanotherdrugorproduct.(19 ) Outsourcingfacility meansa singlephysicallocationregisteredasanouts ourcingfacilityunderthefederalDrugQualit yandSecurityAct, ,at whichsterilecompoundingof a drugorproductisconducted.(20) Compoundedsterileproduct meansa drugthatis intendedforparenteraladministration,anop hthalmicororalinhalationdrugin aqueousformat,ora drugorproductthatisrequiredtobesterileun derfederalorstatelaworrule,whichis producedthroughcompound-ing,butis , 7, ;s.

8 322, ; ,15, ; , 3, ; , 2, ;s. 1, ;s. 36, ;s. 3, ;s. 29, ;s. 1, ; , 26,27, ;s. 1, ;s. 1, ;s. 59, ;s. 6, ;s. 4, ;s. 123, ;s. 239, ; , ; , ; , ; , ;s. 1, ;s. 2, ;s. 2, ;s. 1, (1)TheBoardofPharmacyiscreatedwithinthed epartmentandshallconsistofninememberstob eappointedbytheGovernorandconfirmedbythe Senate.(2)Sevenmembersoftheboardmustbeli censedpharmacistswhoareresidentsofthisst ateandwhohavebeenengagedin thepracticeoftheprofessionofpharmacyinth isstateforatleast4 yearsand,totheextentpracticable, ,twomustbecurrentlyengagedin thepracticeofpharmacyinacommunitypharmac y,twomustbecurrentlyengagedinthepractice ofpharmacyinaClassIIinstitutionalpharmac yor a ModifiedClassII institutionalpharmacy,andthreemustbephar macistslicensedinthisstateirrespectiveof consumermemberwhoisinanywayconnectedwith a drugmanufactureror accordancewiththissubsectionasmembers termsexpireorasavacancyoccursuntilthecom positionoftheboardcomplieswiththerequire mentsofthissubsection.

9 (3)Asthetermsofthemembersexpire,theGover norshallappointsuccessorsfortermsof4year s,andsuchmembersshallserveuntiltheirsucc essorsareappointed.(4)Allprovisionsof chapter456relatingto , 7, ; , 3, ; , 26,27, ; , ; , ; , ; , ; , ;s. 88, ;s. 67, ;s. 124, ;s. 1, (1) , 7, ; , 3, ; , 26,27, ; , ;s. 6, ;s. 4, ;s. 126, ;expenditures. Allmoneysreceivedunderthischaptershallbe depositedandexpendedpursuantto theprovisionsof s. , 7, ; , 3, ; ,27, ;s. 59, ;s. 6, ;s. 4, ;s. 68, ;s. 125, (1)Anypersondesiringtobelicensedasa :(a)Completedtheapplicationformandremitt edanexaminationfeesetbytheboardnottoexce ed$100plustheactualperapplicantcosttothe departmentforpurchaseofportionsoftheexam inationfromtheNationalAssociationof Boardsof Pharmacyor a (b)Submittedsatisfactoryproofthatsheor heis notlessthan18 recipientofa degreefroma schoolorcollegeofpharmacyaccreditedbyana ccreditingagencyrecognizedandapprovedbyt heUnitedStatesOfficeofEducation.

10 Graduateofa 4-yearundergraduatephar-macyprogramofasc hoolorcollegeofpharmacylocatedoutsidethe UnitedStates,hasdemonstratedproficiencyi nEnglishbypassingboththeTestofEnglishasa ForeignLanguage(TOEFL)andtheTestofSpoken English(TSE),haspassedtheForeignPharmacy GraduateEquivalencyExaminationthatisappr ovedbyruleoftheboard,andhascompletedamin imumof500hoursina supervisedworkactivityprogramwithinthiss tateunderthesupervisionofapharmacistlice nsedbythedepartment,whichprogramis approvedbytheboard.(c) ,080hours,allofwhichmaybeobtainedpriorto graduation.(2)Thedepartmentmaypermitanap plicantwhohassatisfiedallrequirementsofs ubsection(1),exceptthoserelatingtoageort heinternshipprogram,totakethewrittenexam ination,butthepassingoftheexam-inationsh allconfernorightsorprivilegesupontheappl icantin connectionwiththepracticeof pharmacyinthisstate.(3)Exceptasprovidedi nsubsection(2),thedepartmentshallissuea licensetopracticepharmacytoanyapplicantw hosuccessfullycompletestheexaminationin , 7, ; ,15,23,25,30,34,62, ; , 3, ;s.