FIRSTREGULARSESSION HOUSEBILLNO.1188 103RDGENERALASSEMBLY INTRODUCEDBYREPRESENTATIVEHEWKIN. 2703H.01I JOSEPHENGLER,ChiefClerk ANACT Torepealsection338.010,RSMo,andtoenactinlieuthereoftwonewsectionsrelatingtothe dispensingofinsulin. BeitenactedbytheGeneralAssemblyofthestateofMissouri,asfollows: SectionA.Section338.010,RSMo,isrepealedandtwonewsectionsenactedinlieu 2thereof,tobeknownassections338.010and338.740,toreadasfollows: 338.010.1.The"practiceofpharmacy"includes: 2 (1)Theinterpretation,implementation,andevaluationofmedicalprescriptionorders, 3includinganylegenddrugsunder21U.S.C.Section353,andthereceipt,transmission,or 4handlingofsuchordersorfacilitatingthedispensingofsuchorders; 5 (2)Thedesigning,initiating,implementing,andmonitoringofamedication 6therapeuticplaninaccordancewiththeprovisionsofthissection; 7 (3)Thecompounding,dispensing,labeling,andadministrationofdrugsanddevices 8pursuanttomedicalprescriptionorders; 9 (4)TheorderingandadministrationofvaccinesapprovedorauthorizedbytheU.S. 10FoodandDrugAdministration,excludingvaccinesforcholera,monkeypox,Japanese 11encephalitis,typhoid,rabies,yellowfever,tick-borneencephalitis,anthrax,tuberculosis, 12dengue,Hib,polio,rotavirus,smallpox,andanyvaccineapprovedafterJanuary1,2023,to 13personsatleastsevenyearsofageortheagerecommendedbytheCentersforDisease 14ControlandPrevention,whicheverisolder,pursuanttojointpromulgationofrules 15establishedbytheboardofpharmacyandthestateboardofregistrationforthehealingarts 16unlessrulesareestablishedunderastateofemergencyasdescribedinsection44.100; EXPLANATION—Matterenclosedinbold-facedbrackets[thus] intheabovebillisnotenactedandis intendedtobeomittedfromthelaw.Matterinbold-facetypeintheabovebillisproposedlanguage. 17 (5)Theparticipationindrugselectionaccordingtostatelawandparticipationindrug 18utilizationreviews; 19 (6)Theproperandsafestorageofdrugsanddevicesandthemaintenanceofproper 20recordsthereof; 21 (7)Consultationwithpatientsandotherhealthcarepractitioners,andveterinarians 22andtheirclientsaboutlegenddrugs,aboutthesafeandeffectiveuseofdrugsanddevices; 23 (8)Theprescribinganddispensingofanynicotinereplacementtherapyproductunder 24section338.665; 25 (9)ThedispensingofHIVpostexposureprophylaxispursuanttosection338.730; 26[and] 27 (10)Thedispensingofanemergencysupplyofinsulinundersection338.740; 28and 29 (11)Theofferingorperformingofthoseacts,services,operations,ortransactions 30necessaryintheconduct,operation,managementandcontrolofapharmacy. 31 2.Nopersonshallengageinthepracticeofpharmacyunlessheorsheislicensed 32undertheprovisionsofthischapter. 33 3.Thischaptershallnotbeconstruedtoprohibittheuseofauxiliarypersonnelunder 34thedirectsupervisionofapharmacistfromassistingthepharmacistinanyofhisorherduties. 35Thisassistanceinnowayisintendedtorelievethepharmacistfromhisorherresponsibilities 36forcompliancewiththischapterandheorshewillberesponsiblefortheactionsofthe 37auxiliarypersonnelactinginhisorherassistance. 38 4.Thischaptershallnotbeconstruedtoprohibitorinterferewithanylegally 39registeredpractitionerofmedicine,dentistry,orpodiatry,orveterinarymedicineonlyforuse 40inanimals,orthepracticeofoptometryinaccordancewithandasprovidedinsections 41195.070and336.220inthecompounding,administering,prescribing,ordispensingofhisor 42herownprescriptions. 43 5.Apharmacistwithacertificateofmedicationtherapeuticplanauthoritymay 44providemedicationtherapyservicespursuanttoawrittenprotocolfromaphysicianlicensed 45underchapter334topatientswhohaveestablishedaphysician-patientrelationship,as 46describedinsubdivision(1)ofsubsection1ofsection191.1146,withtheprotocolphysician. 47Thewrittenprotocolauthorizedbythissectionshallcomeonlyfromthephysicianandshall 48notcomefromanurseengagedinacollaborativepracticearrangementundersection 49334.104,orfromaphysicianassistantengagedinacollaborativepracticearrangementunder 50section334.735. 51 6.Nothinginthissectionshallbeconstruedastopreventanyperson,firmor 52corporationfromowningapharmacyregulatedbysections338.210to338.315,providedthat 53alicensedpharmacistisinchargeofsuchpharmacy. HB1188 2 54 7.Nothinginthissectionshallbeconstruedtoapplytoorinterferewiththesaleof 55nonprescriptiondrugsandtheordinaryhouseholdremediesandsuchdrugsormedicinesas 56arenormallysoldbythoseengagedinthesaleofgeneralmerchandise. 57 8.Nohealthcarrierasdefinedinchapter376shallrequireanyphysicianwithwhich 58theycontracttoenterintoawrittenprotocolwithapharmacistformedicationtherapeutic 59services. 60 9.Thissectionshallnotbeconstruedtoallowapharmacisttodiagnoseor 61independentlyprescribepharmaceuticalsexcepttotheextentdescribedundersection 62338.740. 63 10.Thestateboardofregistrationforthehealingarts,undersection334.125,andthe 64stateboardofpharmacy,undersection338.140,shalljointlypromulgaterulesregulatingthe 65useofprotocolsformedicationtherapyservices.Suchrulesshallrequireprotocolstoinclude 66provisionsallowingfortimelycommunicationbetweenthepharmacistandtheprotocol 67physicianorsimilarbodyauthorizedbythissection,andanyotherpatientprotection 68provisionsdeemedappropriatebybothboards.Inordertotakeeffect,suchrulesshallbe 69approvedbyamajorityvoteofaquorumofeachboard.Neitherboardshallseparately 70promulgaterulesregulatingtheuseofprotocolsformedicationtherapyservices.Anyruleor 71portionofarule,asthattermisdefinedinsection536.010,thatiscreatedundertheauthority 72delegatedinthissectionshallbecomeeffectiveonlyifitcomplieswithandissubjecttoallof 73theprovisionsofchapter536and,ifapplicable,section536.028.Thissectionandchapter 74536arenonseverableandifanyofthepowersvestedwiththegeneralassemblypursuantto 75chapter536toreview,todelaytheeffectivedate,ortodisapproveandannularuleare 76subsequentlyheldunconstitutional,thenthegrantofrulemakingauthorityandanyrule 77proposedoradoptedafterAugust28,2007,shallbeinvalidandvoid. 78 11.Thestateboardofpharmacymaygrantacertificateofmedicationtherapeutic 79planauthoritytoalicensedpharmacistwhosubmitsproofofsuccessfulcompletionofa 80board-approvedcourseofacademicclinicalstudybeyondabachelorofscienceinpharmacy, 81includingbutnotlimitedtoclinicalassessmentskills,fromanationallyaccreditedcollegeor 82university,oracertificationofequivalenceissuedbyanationallyrecognizedprofessional 83organizationandapprovedbytheboardofpharmacy. 84 12.Anypharmacistwhohasreceivedacertificateofmedicationtherapeuticplan 85authoritymayengageinthedesigning,initiating,implementing,andmonitoringofa 86medicationtherapeuticplanasdefinedbyawrittenprotocolfromaphysicianthatmaybe 87specifictoeachpatientforcarebyapharmacist. 88 13.Nothinginthissectionshallbeconstruedtoallowapharmacisttomakea 89therapeuticsubstitutionofapharmaceuticalprescribedbyaphysicianunlessauthorizedby 90thewrittenprotocolorthephysician'sprescriptionorder. HB1188 3 91 14."Veterinarian","doctorofveterinarymedicine","practitionerofveterinary 92medicine","DVM","VMD","BVSe","BVMS","BSe(VetScience)","VMB","MRCVS",or 93anequivalenttitlemeansapersonwhohasreceivedadoctor'sdegreeinveterinarymedicine 94fromanaccreditedschoolofveterinarymedicineorholdsanEducationalCommissionfor 95ForeignVeterinaryGraduates(EDFVG)certificateissuedbytheAmericanVeterinary 96MedicalAssociation(AVMA). 97 15.Inadditiontootherrequirementsestablishedbythejointpromulgationofrulesby 98theboardofpharmacyandthestateboardofregistrationforthehealingarts: 99 (1)Apharmacistshalladministervaccinesbyprotocolinaccordancewithtreatment 100guidelinesestablishedbytheCentersforDiseaseControlandPrevention(CDC); 101 (2)Apharmacistwhoisadministeringavaccineshallrequestapatienttoremainin 102thepharmacyasafeamountoftimeafteradministeringthevaccinetoobserveanyadverse 103reactions.Suchpharmacistshallhaveadoptedemergencytreatmentprotocols. 104 16.Inadditiontootherrequirementsbytheboard,apharmacistshallreceive 105additionaltrainingasrequiredbytheboardandevidencedbyreceivingacertificatefromthe 106boarduponcompletion,andshalldisplaythecertificationinhisorherpharmacywhere 107vaccinesaredelivered. 108 17.Apharmacistshallinformthepatientthattheadministrationofavaccinewillbe 109enteredintotheShowMeVaxsystem,asadministeredbythedepartmentofhealthandsenior 110services.Thepatientshallattesttotheinclusionofsuchinformationinthesystembysigning 111aformprovidedbythepharmacist.Ifthepatientindicatesthatheorshedoesnotwantsuch 112informationenteredintotheShowMeVaxsystem,thepharmacistshallprovideawritten 113reportwithinfourteendaysofadministrationofavaccinetothepatient'shealthcareprovider, 114ifprovidedbythepatient,containing: 115 (1)Theidentityofthepatient; 116 (2)Theidentityofthevaccineorvaccinesadministered; 117 (3)Therouteofadministration; 118 (4)Theanatomicsiteoftheadministration; 119 (5)Thedoseadministered;and 120 (6)Thedateofadministration. 121 18.Apharmacistlicensedunderthischaptermayorderandadministervaccines 122approvedorauthorizedbytheU.S.FoodandDrugAdministrationtoaddressapublichealth 123need,aslawfullyauthorizedbythestateorfederalgovernment,oradepartmentoragency 124thereof,duringastateorfederallydeclaredpublichealthemergency. 338.740.1.Notwithstandinganyotherprovisionoflaw,apharmacistmay 2dispenseanemergencysupplyofinsulintoapatientwithoutacurrent,valid 3prescriptionif: HB1188 4 4 (1)Thepharmacistmakeseveryreasonableattemptbutisunabletoobtain 5authorizationtorefilltheprescriptionfromtheprescribinghealthcareprovideror 6anotherhealthcareproviderresponsibleforthepatient'scare; 7 (2)Either: 8 (a)Thepharmacisthasarecordofaprescriptionatthepharmacyorhasbeen 9presentedproofofarecentprescriptionfortheinsulininthenameofthepatientwhois 10requestingtheemergencysupply;or 11 (b)Inthepharmacist'sprofessionaljudgment,therefusaltodispensean 12emergencysupplyoftheinsulinwillendangerthepatient'shealthordisruptessential 13drugtherapyforachronicconditionofthepatient; 14 (3)Theamountofinsulindispenseddoesnotexceedtheamountofthemost 15recentprescriptionorthestandardquantityorunit-of-usepackageofthedrug;and 16 (4)Theprescriberofthedrughasnotindicatedthatnoemergencyrefillsare 17authorized. 18 2.Apharmacist,thepharmacist'semployer,andtheoriginalprescriberofthe 19drugarenotcivillyliableforanactoromissioninconnectionwiththedispensingof 20insulinunderthissectionunlesstheactoromissionconstitutesnegligence,recklessness, 21orwillfulorwantonmisconduct. 22 3.Theboardofpharmacyshalladoptrules,inconsultationwiththestateboard 23ofregistrationforthehealingartsandthestateboardofnursing,toestablishstandard 24proceduresforpharmaciststofollowindispensinginsulinunderthissection.Therules 25adoptedshallincludedocumentationrequirementsforapharmacisttocompletewhen 26dispensinginsulinwithoutacurrentprescription.Anyruleorportionofarule,asthat 27termisdefinedinsection536.010,thatiscreatedundertheauthoritydelegatedinthis 28sectionshallbecomeeffectiveonlyifitcomplieswithandissubjecttoallofthe 29provisionsofchapter536and,ifapplicable,section536.028.Thissectionandchapter 30536arenonseverableandifanyofthepowersvestedwiththegeneralassembly 31pursuanttochapter536toreview,todelaytheeffectivedate,ortodisapproveandannul 32arulearesubsequentlyheldunconstitutional,thenthegrantofrulemakingauthority 33andanyruleproposedoradoptedafterAugust28,2025,shallbeinvalidandvoid. ✔ HB1188 5