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.(13) Practiceoftheprofessionofpharmacy in-cludescompounding,dispensing,andconsu ltingcon-cerningcontents,therapeuticvalu es,andusesofanymedicinaldrug;consultingc oncerningtherapeuticva-luesandinteractio nsofpatentorproprietaryprepara-tions,whe therpursuanttoprescriptionsorintheabsenc eandentirelyindependentof suchprescriptionsororders.

5 , 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. 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.

6 (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.

7 322, ; ,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.(3)Asthetermsofthe membersexpire,theGovernorshallappointsuc cessorsfortermsof4years,andsuchmemberssh allserveuntiltheirsuccessorsareappointed .

8 (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; graduateofa 4-yearundergraduatephar-macyprogramofasc hoolorcollegeofpharmacylocatedoutsidethe UnitedStates,hasdemonstratedproficiencyi nEnglishbypassingboththeTestofEnglishasa ForeignLanguage(TOEFL)andtheTestofSpoken English(TSE),haspassedtheForeignPharmacy GraduateEquivalencyExaminationthatisappr ovedbyruleoftheboard,andhascompletedamin imumof500hoursina supervisedworkactivityprogramwithinthiss tateunderthesupervisionofapharmacistlice nsedbythedepartment,whichprogramis approvedbytheboard.

9 (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. 30, ; , 26,27, ;s. 13, ;s. 59, ;s. 6, ;s. 4, ;s. 240, ;require-ments;fee. (1)Thedepartmentshallissuea licensebyen-dorsementtoanyapplicantwhoap pliestothedepart-mentandremitsa nonrefundablefeeofnotmorethan$100,assetb ytheboard,andwhomtheboardcertifies:(a) (1)(b)and(c);(b)Hasobtaineda passingscore,asestablishedbyruleoftheboa rd,onthelicensureexaminationoftheNationa lAssociationof Boardsof Pharmacyor a similarnationallyrecognizedexamination,i f theboardcertifiesthattheapplicanthastake ntherequiredexamination;(c) ,includingpracticeincommunityorpublichea lthbypersonsemployedbya govern-mentalentity,in anotherjurisdictionforat least2 of theimmediatelypreceding5 yearsorevidenceof success-fulcompletionof board-approvedpostgraduatetrainingora board-approvedclinicalcompetencyexaminat ionwithintheyearimmediatelyprecedingappl icationforlicensure; (1)(c)withinthe2yearsimmediatelyprecedin gapplication;and(d)Hasobtaineda passingscoreonthepharmacyjurisprudencepo rtionsofthelicensureexamination,asrequir edbyboardrule.

10 (2)Anapplicantlicensedinanotherstatefora periodin excessof 2 yearsfromthedateof applicationforlicensurein thisstateshallsubmita totalofatleast30hoursofboard-approvedcon tinuingeducationforthe2 calendaryearsimmediatelyprecedingapplica tion.(3)Thedepartmentmaynotissuea licensebyendorsementtoanyapplicantwhois underinvestiga-tioninanyjurisdictionfora nactoroffensethatwouldconstitutea violationofthischapteruntiltheinvestiga- tioniscomplete, (4)Thedepartmentmaynotissuea licensebyendorsementto anyapplicantwhoselicenseto practicepharmacyhasbeensuspendedorrevoke dinanotherstateorwhois currentlythesubjectofanydisciplinaryproc eedingin , ;s. 1, (1)Thedepartmentshallrenewalicenseuponre ceiptoftherenewalapplication,verificatio nofcom-pliancewiths. ,andreceiptofa feesetbytheboardnottoexceed$250.(2)Thede partmentshalladoptrulesestablishingaproc edureforthebiennialrenewaloflicenses.(3) Anypersonlicensedunderthischapterfor50ye arsormoreisexemptfromthepaymentoftherene walordelinquentfee,andthedepartmentshall issuea lifetimelicensetosucha , 7, ; , 3, ; , 26,27, ;s.