Providing Drugs and Medical Devices To Patients

WashingtonPharmacyLaw:AUsersGuide2017
THIS PREPUBLICATION DRAFT IS SUPPLIED FOR INSTRUCTIONAL USE

ONLY AT WASHINGTON STATE UNIVERSITY
4PROVIDINGDRUGSANDMEDICAL
DEVICESTOPATIENTS

REGULATIONOFFOOD,COSMETICS,DRUGS,ANDDEVICES
TheFoodandDrugAdministration167isresponsibleforregulatingfoods,drugs,cosmetics,andmedicaldevices
intheUnitedStates,underauthorityoftheFood,DrugandCosmeticAct168(FDCA21USCChapter9).
TheFDAwebsiteprovidesseveralarticlesontheHistoryoftheFDA169andthefoodanddruglaws.
THEPUREFOODANDDRUGACT,alsoknownastheWileyLaw,waspassedin1906,asthefirst
comprehensivefederalstatutetoassurepurityandtruthfullabelingforfoodsanddrugs.
TheActrequiredaccuratelabeling,andattemptedtoassure
thatfoodanddrugswerepure,i.e.,containedonlywhat COMPETENCYAREASINTHIS
shouldbeinwholesomefoodorthedrugaslabeled. CHAPTER
2016MPJECOMPETENCYSTATEMENTS
Twowaysinwhichdrugsorfoodcouldviolatetheact: Areas1.1.1,1.2.1,1.2.2,1.3.1,1.3.2,1.3.3,
1.3.4,1.3.6,1.4.1,1.4.2,1.4.3,1.4.5,1.4.6,
ADULTERATION,whichisthepresenceofanyadded 1.4.7,1.4.8,1.4.9,1.4.11,1.4.15,1.6.1,1.6.2,
injurioussubstance,foodwhichisdeteriorated,contains 1.6.3,1.8.1,1.8.2,1.8.3,1.8.4,2.3.3,3.1.1
toxicsubstances,drugswhichdifferfromcompendia 2016ACPEREQUIREDELEMENTSPharmacy
standards,orfoodordrugswhicharestoredinunsanitary Law&RegulatoryAffairs;Medication
placesoratimpropertemperatures.After1962,includes Dispensing,DistributionandAdministration
failuretobeproducedinaccordancewithGMPs(seebelow).
MISBRANDINGconsistedin1906offalseandfraudulentstatementsonthelabel.Currently,misbranding
includesanyfalseormisleadingstatementsinthelabeling,whichincludesboththelabelaswellasany
additionalstatementsabouttheproductmadebyitsmanufacturer.170
FOOD,DRUGANDCOSMETICACT(FDCA).Growingproblemswithmodernchemicals,andlimitson
theapplicabilityoftheWileyLaw,ledtothepassagein1938oftheFDCA,thathasbeenamendedseveraltimes
sincethen.AmajorimpetustothepassageoftheFDCAwasaninfluentialbookbyRuthDeForestLamb,
AmericanChamberofHorrors.171AprecipitatingeventwasthemarketingbytheS.E.MassengillCompanyof
SulfanilamideElixir,172whichcontaineddiethyleneglycolasthesolvent107deathsoccurredbeforetheFDA
couldgettheproductremovedfromthemarket.TheFDCAisoftenreferredtoasthe1938law.
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WILLIAME.FASSETT
NEWDRUGS.Alldrugsmarketedafter1938arenewdrugs.The
FDCArequiredthatmanufacturersofnewdrugsPROVIDEPROOF
OFSAFETYBEFOREMARKETINGDRUGS.Thelawspecifiedthatnew
drugmeansanydrugthecompositionofwhichisnotgenerally
recognized,amongexpertsqualifiedbyscientifictrainingand
experiencetoevaluatethesafetyandeffectivenessofdrugs,assafe
fortheuseundertheconditionsprescribed,recommended,or
suggestedinthelabelingthereofDrugsgenerallyrecognizedas
safe(GRAS)werenotnewdrugs.Otherproductsrequiredproofof
safetypriortomarketing.
ThelawalsorequiresthatmanufacturersOBTAINPREMARKETING
APPROVALofnewdrugsbytheFDA.Approvalwastobesoughtby
filingofaNEWDRUGAPPLICATION(NDA)withtheFDA.
HOMEOPATHICDRUGS.TheFDCA'sdefinitionofa"drug"includes
itemslistedasofficialintheHomeopathicPharmacopeiaofthe
UnitedStates(HPUS).Homeopathyemergedasamedicaltheory
FIGURE41.ELIXIRSULFANILAMIDE
suggestingthatdrugsproducingsymptomssimilartothoseofthe
underlyingdiseasewouldactacurativesforthatcondition("likecures
like").Forexample,capsicum(derivedfromcayennepepper)isthoughttostimulatebloodflowandsweating
andisananodyneforstingingpain,sincecapsicumitselfproducessuchpain.Thechiefproponentof
homeopathywasSamuelHahnemann(c.1796)andtheprinciplesheelucidatedincludethenotionthatthe
moredilutethedrug,themorepowerfulitis.Themostpotenthomeopathicremediesarepreparedbyaseries
of100folddilutions;expressedasfactorsofC(e.g.,6Chasaconcentrationof1: 10 ).Hahnemannissaidto
haveadvocated30Cdilutions,oradilutionbyafactorof10 .Aboveabout13C,theconcentrationofthedrug
fallsbelow1 10 ,whichislessdilutethanthereciprocalofAvogadro'snumber;thustherewouldnotlikely
beasinglemoleculeofthedrugleftintheresultingsolution.Homeopathicpractitionersoftenassertthatthe
compoundingprocessmodifiesthewatertogiveitthe"memory"ofthedrugsubstance.
OTCversionsofhomeopathicremediesarelabeledinconcentrationsexpressingfactorsof"X",or10fold
dilutions.TheoriginalversionZicamColdRemedynasalspraywaslabeledwith2Xzincacetateand1Xzinc
gluconate;or1:100zincacetateand1:10zincgluconate(currentversionsofthenasalswabsarelabeledwith
activeingredientsthatinclude"Galphimiaglauca4x;Luffaoperculata4x,andSabadilla4x").
Prescriptionversionsofhomeopathicremediesaredispensedbylicensedpractitioners,includingnaturopaths.
OTCversionsaretreatedbyFDAasiftheywereherbalremediesandgenerallyonlyactedonif,liketheoriginal
Zicamwhichallegedlycausedanosmiaadverseeffectsemerge.173However,theFederalTradeCommissionis
nowevaluatingmarketingclaimsforOTChomeopathicproductswithgreaterscrutiny(seebelow).
OLDDRUGS.Drugsmarketedpriorto1938arenotcoveredbytheFDCA,unlesschangesaremadeintheir
formulationorlabeling.Examplesoftheseolddrugsincludesomedosageformsofphenobarbitalandvarious
narcoticdrugs.TheFDAbelievesthatfew,ifanyofthepre1938drugsnowmarketedareintheiroriginal
formulationorlabeling,andthusrequiresubmissionofaNDAtoallowthemtobemarketedlegally.
IDENTICAL,RELATED,ORSIMILARDRUGS.After1938andbeforethesubsequentpassageoftheKefauver
Harrisamendmentsin1962,wheneverFDAapprovedaNewDrug,allexisting(pre1938)drugsthatwere
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identical,related,orsimilar(IRS)tothenewdrug
werealsoconsideredapproved,andweremarketed FEDERALFOOD,DRUG,AND
withoutevercompletingaspecificNDAforthe COSMETICACTANDITSMAJOR
product.
AMENDMENTS
GENERALLYRECOGNIZEDASSAFE.Alsobetween FDCA1938(ReplacedPureFoodandDrug
1938and1962,manymanufacturersintroduceddrug Act,establishedproofofsafetypriorto
productsintothemarketbasedontheirown marketing)
conclusionthatthedrugsweregenerallyrecognized DURHAMHUMPHREYAMENDMENTS1951
assafe(GRAS)ORbasedonopinionsfromtheFDA (RxOnly)
thatthedrugswerenotnewdrugs.TheFDAformally
KEFAUVERHARRISAMENDMENTS1962
revokedalltheseopinionsin1968(21CFR310.100).
(EffectiveaswellasSafe)
PRESCRIPTIONONLYDRUGS.Priorto1951, MEDICALDEVICEAMENDMENTS1976
pharmacistscoulddispensemostdrugsexcept (Establishedsafetyandeffectiveness
narcoticswithoutaprescription.Asamatterof requirementsformedicaldevices)
professionalethicsandcourtesy,however,most ORPHANDRUGACT1983(Economic
pharmacistsrequiredprescriptionsformanydrugs, amendmenttobringlowdemanddrugsto
althoughrefillproceduresweresomewhatlax.After market)
1951,however,theDURHAMHUMPHREY174
WAXMANHATCHAMENDMENTS1984
AMENDMENTScreatedanewclassofdrugsthatcould
(Economicamendmenttoallowmarketingof
notbedispensedwithoutaprescription.Thesehave
generics,extendpatentlife)
becomecalledLEGENDDRUGS,becausetheywere
requiredtobearalegendontheirlabel:Caution: PRESCRIPTIONDRUGMARKETINGACT1987
FederalLawprohibitsdispensingwithout (Economicamendmentrestrictreimportation
prescription. ofdrugsfromoutsideofUS,restrict
distributionofsamples,regulatewholesalers)
Allexistingdrugscouldbesoldoverthecounter FDAMA1997(RegulatoryreformofFDA,
(OTC),withoutprescription.
createsafeharborforpharmacycompounding
Newdrugsthatcouldnotbearadequatelabelingfor in503A,createuserfees)
safeusebytheconsumerwouldnowbeabletobe FDAAA2007(Reauthorizeuserfees,give
marketedifinformationwasprovidedtothe morepowertoFDAregardingdrugsafety
physician,andtheserequiredaprescription. issues,establishREMS)
Thelawallowedfororalprescriptions,andforrefills. FDASIA2012(Reauthorizeandexpanduser
fees,reformrulesregardingpediatricdrugs,
KEFAUVERHARRISAMENDMENTS dealwithdrugshortages)
EFFECTIVENESSREQUIRED.In1962,additional DRUGQUALITY&SECURITYACT2013
amendments,theKEFAUVERHARRIS (Reinstate503A,establishoutsourcing
AMENDMENTS,175werepassed,triggeredbyproblems facilities,establish10yeartimelinefortrack
withthalidomide,176adrugwhichhadnotactually andtracedrugsupplychainsecurity)
beenmarketedintheUS,butwhichcausedbirth 21STCENTURYCURESACT2016(Multiple
defects(phocomelia)inmanybabiesborninEurope revisionsofrequirementsfordrug
andCanada.However,thestagewassetforthe developmentandapproval)
legislationbyaseriesofhearingsledbySenator
KefauversSenateCommitteeonAntitrustand
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WILLIAME.FASSETT
Monopolystartingin1959,whichwereinitiallyfocusedondrugpricingandmonopolyissues.The1962
amendmentsrequired:
Proofofefficacy(effectiveness)aswellassafetypriortomarketing.
EstablishedregulationscalledGoodManufacturingPractices(GMPs)requiringsignificantmonitoringof
manufacturersfacilitiesandprocesses
MovedcontrolofadvertisingforRxdrugsfromtheFederalTradeCommissiontotheFDA
Improvedproceduresandrequirementsforobtaininginformedconsentduringclinicaltrialsofnew
drugs.
GENERALLYRECOGNIZEDASSAFEANDEFFECTIVE(GRASE).TheGRASEstatusisconferredonexisting
products,especiallyforOTCuse,thatmeetthe1962standards.
DRUGEFFICACYREVIEW.The1962amendmentsmandatedtheFDAtoreviewtheefficacyofdrugswhichwere
previouslyapprovedonlyonthebasisofsafety.Theresultofthisreviewleftthreecategoriesofdrugsonthe
market.
APPROVEDDRUGPRODUCTS.Allprescriptiondrugsmarketedbetween1938and1962forwhichanNDAwas
approvedonthebasisofsafetyonlywerereviewedinalonglastingeffortbyFDAknownastheDrugEfficacy
StudyImplementation(DESI).
60panelsofexpertsreviewedsubmissionsofevidencefromthemanufacturers,andclassifiedeachproposed
indicationforaproductasineffective,ineffectiveasafixedcombination,possiblyeffective,probably
effective,oreffective.Onlythoseproductswhichwerefoundtohaveatleastoneeffectiveindicationcould
continuetobemarketed.
DrugswithnoeffectiveindicationsweregivenaNoticeofanOpportunityforHearing(NOOH),andan
opportunitytosubmitdatatosubstantiatetheeffectivenessoftheirclaims.Drugswithoutaneffective
indicationarecalledLessthaneffectiveproducts(LTE).
Of3,400productsreviewed,over1,000wereremovedfromthemarketbythisprocess.177
NONPRESCRIPTION(OVERTHECOUNTEROROTC)DRUGSwereseparatedfromtheDESIprocessin1972and
potentialOTCingredientsweresubjecttoareviewbygroupsofexpertsformedintoOTCReviewPanels.These
expertpanelsdevelopedmonographsfortherapeuticclassesofdrugs(e.g.,antacids,coldremedies).Products
comprisedofingredientslistedinthesemonographs,andformulatedinconformancewiththemonographs,
maybeusedinformulatingOTCproductswithoutsubmissionofanNDA.178
DRUGSFORWHICHANNDAWASNEVERAPPROVED.
Atleast6categoriesofdrugsmightstillbefoundontheUSmarketthathaveneverbeensubjecttoanapproved
NDA:
DRUGSSTILLPARTOFTHEDESIPROCESS.Believeitornot,over50yearsafterthepassageofthe
KefauverHarrisamendments,somedrugsarebeingmarketedsubjecttotheongoing[DESI]reviewas
of2014,includingDonnatal(belladonnaandphenobarbital)andLibrax(chlordiazepoxideand
clidiniumbromide).179
DRUGSIRSTOAWITHDRAWNDESIDRUG.DrugproductswhichwerenotincludedintheDESI
program,butwhichareidentical,related,orsimilar(IRS)toaDESIproductwhichwaswithdrawn.
DRUGSIRSTOANEFFECTIVEDESIDRUGWITHNONDA.DrugproductswhichareIRStoaDESIproduct
whichwasfoundeffective,butforwhichanNDAhasneverbeenfiledorapproved.
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PRESCRIPTIONDRUGWRAPUPDRUGS.Thesedrugsincludethosethatwerenotapprovedpriorto
1962andarenotIRStoDESIdrugs,plusthemajorityofpre1938drugsthattheFDAbelievesareno
longercoveredbythegrandfatherclausesofthe1938and1962acts.
DRUGSFIRSTMARKETEDAFTER1962ORCHANGEDAFTER1962WITHOUTANNDA.
OTCPRODUCTSTHATDONOTCOMPLYWITHTHEOTCMONOGRAPHSANDDONOTHAVEINDIVIDUAL
APPROVEDNDAS.
UNAPPROVEDDRUGSTODAY.TheFDAissuedaCompliancePolicyGuideonMarketingUnapprovedDrugs(CPG
Section440100)inJune2006thatallowedtheagencytotakeacloserlookatpre1938drugsandpossibly
removethemfromthemarket,orrequiremanufacturerstobringmarketonlydosageformsthathavemetFDCA
requirements.Theguidewasupdatedandrevisedin2011.180
REMOVINGUNAPPROVEDDRUGSfromthemarketisarenewedinitiativeoftheFDA,andpharmacistswillbe
facingmoreissuessurroundinganestimated2%ofallmarketeddrugswhichcanstillbefoundonpharmacy
shelves.
ENFORCEMENTPRIORITIES.Becauseoflimitedenforcementresources,theFDAhassetapriorityfordealing
withunapproveddrugs,withhighestpriorityassignedto:
Drugswithpotentialsafetyrisks
Drugsthatlackevidenceofeffectiveness
Healthfrauddrugs
DrugsthatpresentdirectchallengestothenewdrugapprovalandOTCmonographsystems
UnapproveddrugsthatspecificallyviolateotherprovisionsoftheFDCA
DrugsthatarereformulatedtoevadeFDAenforcementactions
EnforcementactionslistedontheFDAwebsiteinearly2015haveremovedthefollowingproductsfromthe
marketthatwerebeingmarketedwithoutanapprovedNDA:balancedsaltsolution(ophthalmic);
carbinoxamineproducts;variouscodeineoraldosageforms;colchicineproducts;quininesulfateproducts;
trimethobenzamidesuppositories;andotherunapproveddrugs.181
TheFDAhasalsopursuedlawsuitsundertheFederalFalseClaimsAct(seeChapter8)againstseveral
manufacturers,obtainingsettlementsinexcessof$450millionin2010and2011,withadditionalclaims
pending.
WHENANNDAISAPPROVEDFORAFORMERLYUNAPPROVEDDRUG.TheFDA,onacasebycasebasis,willtake
moreaggressiveactionwhenanapprovedNDAisgrantedforoneproductinaclass,whenothermanufacturers
continuetomarketunapprovedversionsofthedrug.
However,FDAnotedin2011thatitwillbalancetheneedtoprovideincentivesforvoluntarycompliance
againsttheimplicationsofenforcementactionsonthemarketplaceandonconsumerswhoareaccustomedto
usingthemarketedproducts.ThisappearstobeinresponsetotheexperiencewithitsapprovalinFebruary
2011ofMakena(hydroxyprogesteronecaproateinjection)foruseinthreatenedpretermbirths.The
manufacturer(KVPharmaceutical)releasedtheproductat$1,500perdose,orapproximately100timesthecost
ofthedrugwhenitwasbeingcompoundedbypharmacies.ByMarch2011,theFDApubliclyannounceditwould
exercisediscretionandnottakeactionagainstpharmaciescompoundinghydroxyprogesteronecaproate
injectioninfullcompliancewithstatelaws.Themanufacturerreduceditspriceto$690perdose.182,183InJune,
2012,theFDAissuedastatementthatitwouldapplyitsnormalenforcementpoliciestopharmacies
compoundinghydroxyprogesteronecaproate.
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WILLIAME.FASSETT
FEDERALFUNDSCANTBEUSEDFORLTEDRUGS.FederalregulationrelatingtotheMedicaidprogramprohibits
useoffederalfundstopayfordrugswhichhavebeenratedLTE.Ifstateswishtopayforanyofthesedrugs,
theymustdosowithstatefundsonly.Similarly,LTEdrugshavebeenexcludedfromMedicarePartDcoverage.
ECONOMICAMENDMENTS.Otheramendmentssince1976havelargelydealtwitheconomicissues,
includingmarketing,patentrights,andpromotionofgenericdrugs.Theseinclude:
ORPHANDRUGACTOF1983,extendingpatentprotectionandgivingtaxrelieftocompaniesthatdevelop
neededdrugswithoutsignificantmarketpotential.
WAXMANHATCHAMENDMENTOF1984,whichstreamlinedprocessesforapprovalofgenericdrugs,and
gaveextendedtermsofpatentsforcertaindrugs.
PRESCRIPTIONDRUGMARKETINGACTOF1987,whichcontrolsdistributionoflegenddrugsamples,reselling
ofdrugsbyhospitals,andrequiresstatelicensingofdrugwholesalers.(ManyoftheprovisionsofthePDMA
havebeenreplacedbytheDrugSupplyChainSecurityAct(seebelow).)
FDAMA.TheFoodandDrugAdministrationModernizationActof1997createdsignificantchangesinthe
FDCA,predominantlyaffectingmanufacturers.
Requiredstudiesofdrugsinpediatricpatients
SetforthFDAauthoritytoregulatecompoundingofsolutionsusedinPETscans
Createdasystemoffasttrackapprovalsofcriticaldrugs
EstablisheduserfeesforprocessingofNDAs
Simplifiedlabeling,allowsRxonlyinsteadoftheformerlegend
Allowedformanufacturerstodisseminateinformationonofflabelusesthisprovisionisnow
sunsetted
Amajorsectiondealtwithpharmacycompounding,butwasinvalidatedbythe9thCircuitinWesternStates
MedicalCenterv.Shalala,238F.3d1090(2001),andupheldastocertainpartsbytheSupremeCourtin
Thompsonv.WesternStatesMedicalCenter,238F.3d1090(2002).184Subsequentlitigationinthe5thCircuitled
toadecisionthatthesection,absentitsbanonadvertising,remainedvalidinthecircuit.185The5thCircuithas
nowupheldtheprimaryconclusionofthedistrictcourtthatthecompoundingprovisionsofFDAMA,absentthe
banonadvertising,remaininforce.186The2013enactmentoftheDrugQualityandSafetyActreenactedthis
section.(SeesectiononCompounding).
FDAAA.TheFoodandDrugAdministrationAmendmentsActof2007187waspassedprimarilytoreauthorize
theuseofuserfeestosupportFDANDAreviewactivities,andtoallowuserfeesrelatedtoreviewandapproval
ofmedicaldevices.However,severaladditionalreformswereincludedintheAct.Amongthemostimportant
forpharmacistsare:
FDAAUTHORITYTOREQUIRENEWSAFETYLABELINGINPRESCRIPTIONDRUGLABELING.TheFDAcanforcethe
manufacturertoincludespecificnewsafetyinformationintheprescriptiondruglabeling,ratherthan
negotiatethelanguagetobeused.
FDAAUTHORITYTOREQUIREPOSTMARKETINGCLINICALTRIALSFORAPPROVEDDRUGS.TheFDAcannowinsist
thatamanufacturerconductadditionaltrialsonmarketeddrugs:
Toassessaknownseriousriskrelatedtotheuseofthedruginvolved.
Toassesssignalsofseriousriskrelatedtotheuseofthedrug.
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Toidentifyanunexpectedseriousriskwhenavailabledataindicatesthepotentialforaseriousrisk
REMS.TheFDAmayrequiremanufacturerstodevelopRiskEvaluationandMitigationStrategies(REMS)asa
conditionofapprovalofanewdrug,orasapostapprovalrequirementpursuanttonewsafetyinformation.A
REMSmayapplytoasingledrugproductortoanentireclass(e.g.,NSAIDsorlongactingopioids).Alistofdrugs
withapprovedREMSisontheFDAwebsite.188
ELEMENTSOFAREMSPLANMAYINCLUDEANYORALLOFTHEFOLLOWING:
Assessmentsat18months,3years,and7years
MedicationGuideorPPIdevelopment
Communicationplantohealthprofessionals
Accessplanstoinsuresafeusefordrugswithhighrisk,whichmayincludeoneormoreofthefollowing
strategies:
Limitprescribingtoproviderswithspecialtraining
Limitdispensingtocertifiedproviders
Limitadministrationtopatientsincertainsettings
Limitdistributiontopatientswithdocumentationofsafeuseconditions,suchaslaboratorytests
Requiremonitoringforeachpatientreceivingthedrug
Requireeachpatienttobeenrolledinaregistry
ExamplesofcurrentcontrolprogramsthatcouldbeconsideredREMSwithaccessplansincludethecontrolled
distributionandbloodmonitoringsystemforClozaril,andtheiPledge189programforAccutaneprescribing
anddispensing.In2009theFDApublishedaproposedREMSforlongactingopioids,includingfentanyl,
methadone,andlongactingformsofoxycodoneandmorphine.AREMSwasapprovedinJuly2012and
significantlyrevisedinSeptember2013(SeealsoChapter5).
REMSAREENFORCEABLEagainstbothmanufacturersandpractitioners
Thedrugsponsor(manufacturer)maynotintroduceaproductintointerstatecommerceifinviolations
oftheprovisionsofaREMSforthedrug
AdispenserwhodistributesthedruginviolationoftheREMShascreatedamisbrandedproduct
FDAcanimposecivilpenaltiesagainstmanufacturersorproviderswhoviolateFDAAA;andcriminal
penaltiesmaybeimposedonmanufacturers
SomecourtshaveheldthatfailuretodistributearequiredMedicationGuidecouldconstituteevidence
ofnegligenceonthepartofthepharmacist.190
THENATIONALINSTITUTESOFHEALTHWILLEXPANDITSCLINICALTRIALSDATABASE,andmanufacturerswill
berequiredtoprovideinformationonalloftheirsponsoredclinicaltrials.Thisinformationwillbeaccessible
onlinetothegeneralpublic.
THEFDAMAYREQUIREPREBROADCASTREVIEWOFTELEVISIONADVERTISINGFORPRESCRIPTIONDRUGS.
ManufacturersmaysubmitdirecttoconsumeradvertisingforpriorreviewbyFDA.TheFDAmayreviewDTCads
toassurethatthemajorstatementconcerningthedrugsname,conditionsofuse,sideeffectsand
contraindicationsispresentedinaclear,conspicuous,andneutralmanner.
PHARMACISTSMUSTDISTRIBUTETOPATIENTSASIDEEFFECTSSTATEMENT.(Seesectiononprescription
labeling,below.)
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WILLIAME.FASSETT
FDASIA.TheFoodandDrugAdministrationSafetyandInnovationActof2012191isthemostrecentattemptby
CongresstoenhancetheauthorityoftheFDAtodealwithemergingissuesandtechnologies.Itconsistsof11
majorsections(titles):
ReauthorizationandexpansionofuserfeeschargedbyFDAtoreviewapplicationsfornewdrugsand
medicaldevices(TitlesIthroughIV).Theseprovisionsincreasefeelevelsforprescriptiondrugand
medicaldeviceuserfees,andaddnewuserfeesforgenericdrugapplicationsandbiosimilardrugs
applications.
MakespermanenttheprovisionsoftheBestPharmaceuticalsforChildrenActandthePediatric
ResearchEquityActpreviouslyenactedorreenactedaspartofFDAMAandFDAAA(TitleV).
Revisionofregulatoryrequirementsformedicaldevices(TitleVI).
EnhancingFDAsauthoritytoinspectproducersanddistributorsofdrugsthroughoutthedrugsupply
chain(TitleVII).
Incentivestoencouragedevelopmentofproductsforantibioticresistantinfections(TitleVIII).
Expandingtherangeofproductsthatqualifyforacceleratedapproval,includingacategoryof
breakthroughtherapies.(TitleIX).
Addressingtheproblemofdrugshortages(TitleX).
ReauthorizationofcertainportionsofFDAAA,andenactingmiscellaneousprovisionsrelatedtomedical
gases,prescriptiondrugabuse,controlledsubstances,nanotechnology,andcontrolledsubstances,
amongothers.
FDASIAprovisionsarediscussedwhereappropriateinothersectionsofthistext.
BIOLOGICSPRICECOMPETITIONANDINNOVATIONACTOF2009
TheBPCIAisforbiologicalproductsthecounterparttotheHatchWaxmanamendments,andcreatesapathway
forfollowonbiologicalproductsthatarehighlysimilartoareferenceproducttobemarketedwithout
completingafullNDAorBLA.UntilMarch2020,itispossibleforabiologicproducttobeapprovedunderan
NDA,andanapprovedNDAisdeemedequivalenttoalicenseissuedunderaBLA.Followonbiologicsthatare
highlysimilarareapprovedbasedona351Kapplicationtobedeclaredinterchangeable,whichisabiologic
productsalternativetobeingagenericequivalent.TheBPCIAgivesthereferenceproduct12yearsofdata
exclusivityfollowingitsinitialapproval,whichmeansthata351Kapplicationforaninterchangeableproduct
cannotbeapprovedduringthattime.AfterMarch23,2020,biologicproductscannolongerbeapprovedbased
onanNDA,butonlyonthebasisofaBLA.Seefurtherdiscussionofbiologicdrugproductsbelow.
DRUGQUALITY&SECURITYACTOF2013.InNovember2013,largelyinresponsetotheNewEngland
CompoundingCentermeningitisepidemic,192CongresspassedtheDrugQuality&SecurityAct.193Thefirstpart
oftheActdealtwithpharmaceuticalcompounding,andthesecondpartestablisheda10yeartimelinefor
electronictrackandtraceofdrugproducts.SeefollowingsectionsonCompoundingandontheDrugSupply
Chain.
21STCENTURYCURESACTOF2016.Unusualforthe114thCongress,drugindustrylobbyistsgenerated
widespreadbipartisansupportforH.R.34,"AnActtoacceleratethediscovery,development,anddeliveryof21st
centurycures,andforotherpurposes,"otherwiseknownasthe21stCenturyCuresAct.194Itfeatured$6.3billion
ofnewfunding,muchgoingtosupportresearchsupportedbytheNationalInstitutesofHealth(NIH).About$1
billionofthefundingwenttostategrantstofighttheopioidepidemicasenvisionedbytheComprehensive
AddictionandRecoveryAct(CARA),passedearlierin2016(seeChapter5).ItsmajorimpactontheFDCAisto
reviserequirementsfordrugapproval,ostensiblytoexpeditedrugapprovals.Amajorrevisionistoallowthe
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useof"datasummaries,"or"realworldevidence,"suchasobservationalstudies,insuranceclaimsdata,and
anecdotalinformationincludingpatientinput,tosubstituteinsomecasesforcontrolledclinicalstudies.(See
below)TheActstrengthensregulationsrequiringthatinsurerscovermentalhealthtreatmentsonaparwith
coverageforothermedicalconditions(seeChapter8),andprovidesforsomechangestoHIPAArulesfor
"compassionatecommunication"(seeChapter6)anddirectsDHHStorevisepart2of42CFRgoverning
disclosuresforpersonsinsubstanceabusetreatmentprograms(seeChapter5).
PUBLICHEALTHSERVICEACT.195ThePHSAwasenactedin1944andhasbeenamendedfrequentlysincethen.It
isawiderangingsetoffederallawsthathaveasignificantimpactonhealthprofessionals,including
pharmacists.Federallawgoverninghealthmaintenanceorganizations,accountablecareorganizations,research
ethics,healthcarequalityresearch,healthinformationtechnology,andhealthprofessionseducationareall
subsumedwithinthePHSA.Thesocalled340Bdrugpricingprogramisdescribedinsection340bofthePHSA.
TheActalsoprovidesforregulationofbiologicalproductsbytheFDA(seebelow).
RXTOOTCSWITCHES.Mostmodernnewdrugsbegintheirmarketedlivesaslegenddrugs.However,after
sometimeonthemarket,theirgeneralsafetyandusefulnessforthelaypublicmaybecomebetterknown,and
manufacturersmayseektohavethemmovedtoOTCstatus.ThisprocessisknownasanRxtoOTCswitch.
OnewaybywhichRxOTCswitchesareinitiatedisbyCitizensPetitionstotheFDA(whichmaybesubmitted
bythemanufacturer).TheconversionofPlanBfromRxonlytoOTCforwomen15andoverwasinitiatedbya
citizenspetition(andafederallawsuit).
DRUGSTHATAREBOTHRXANDOTC.Afewdrugshaveformanyyearsbeenavailablewithoutprescription,but
restrictedtosaleinapharmacy.Untilveryrecently,theseconsistedalmostexclusivelyofOTCproductsin
ControlledSubstanceScheduleV(seeChapter5),forwhichthepurchaserhadtosignalogbookthatwasalso
signedbyapharmacist.Methamphetamineprecursorproductscontainingephedrine,phenylpropanolamine,or
pseudoephedrinehavenowbeenrestrictedtosaleandrecordinginalogbook,butarenotspecificallyrestricted
tosalebypharmacists(seebelowandChapter5).PlanB(anditsgenerics)requireaprescriptionforpersons
underage17,butmaybesoldwithoutaprescriptiontopersons17andolder.(NotethatPlanBOneStepis
OTCandafterMarch2014therearegenericversionsavailable,suchasNextChoiceOneDose,TakeAction,and
MyWay,andallarelabeledforusebywomenofchildbearingage.)
FDASOLICITSCOMMENTSONACLASSOFBEHINDTHECOUNTER(BTC)DRUGS.InOctoberof2007,theFDA
issuedanoticeofpublicmeeting196toreceiveinputonaproposedclassofBTCdrugs.BTCdrugswouldbe
availablewithoutprescription,butonlyfrompharmacistswhoprovideanappropriatelevelofpatient
assessmentandcounselingpriortodeliveryofthedrugtothepatient.Themostfrequentlymentionedpotential
classofdrugsforBTCstatusisthestatingroupofHMGCoAreductaseinhibitors.Ingeneral,organizedmedicine
(e.g.,theAmericanCollegeofPhysicians197)hasopposedtheconcept,asserting,amongotherthings,that
pharmacistslackthetrainingandtimetoproperlysupervisethedistributionofBTCmedications.TheAmerican
MedicalAssociationtestimonyattheNovemberhearingalsoquestionedwhetherFDAhadstatutoryauthority
toapprovesuchaclass.Pharmacygroupsgenerallysupportedtheconcept,withrecommendationsthatwould
makethedistributionofBTCdrugssubjecttorigorousprocessesdesignedtopromotepatientcare.TheNational
AssociationofBoardsofPharmacy(NABP)hasadvocatedaBTCclassofdrugssince1993.Representativesof
nonpharmacyretailers(e.g.,theFoodMarketingInstitute)andOTCdrugmanufacturerswerenotsupportive.
Consumerrepresentativesweregenerallysupportive.Thecommentperiodwassubsequentlyextendedto
December17,2007.198A2011commentarybyPrayandPraynotedthattherearealreadyseveraldrugsor
devicesthatareavailablewithoutprescriptionbutonlyfrompharmacies,includingolderformsofbeefandpork
insulin,OTCScheduleVcoughsyrups(seechapter5),andsyringes,aswellasmorerecentadditionsof
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WILLIAME.FASSETT
pseudoephedrine,andemergencycontraceptives.199Naloxoneandepinephrineinjectorsarebeinghandledin
thestatesinwaystomakethemmoreaccessible(seebelow).
FDAHOLDSHEARINGONCONDITIONSOFSAFEUSETOEXPANDACCESSTONONPRESCRIPTIONDRUGSIN
2012.200ArevisedparadigmforBTCdrugswasannouncedbyFDAinlateFebruary2012.Underthisnew
approach,FDAwasconsideringwaystomakethedistinctionbetweenprescriptionandnonprescriptiondrugs
lessrigid,sothatcertaindrugscouldbemadeavailabletopatientsunderconditionsofsafeuse.These
conditionswouldrequireapharmacistsinterventionoruseofinnovativetechnologies.Possibleapproaches
wouldinclude
Includingundercertainconditionsofsafeuse:
Requiringpharmacistinterventiontoensureappropriatenonprescriptionuse
UseofinnovativetechnologiesapprovedorclearedbyFDAforuseinthepharmacyorothersetting
Requiringaninitialprescriptionforsomedrugs,butallowingrefillsasanonprescriptionproductunder
conditionsforsafeuse
Somedrugswhichwouldotherwiserequireaprescriptioncouldbeapprovedfornonprescriptionuse
withsometypeofpharmacistinterventionasaconditionofsafeuse
Makingthesamedrugproductsimultaneouslyavailableasbothaprescriptionandnonprescriptiondrug
productwithconditionsofsafeuse
TheFDAhasnotupdateditswebsitecoveringthisissuesinceApril2012,andthesiteiscurrently
"archived."
Thegrowingexpansionofpharmacists'scopeofpracticeandeligibilityforpaymentasprovidersandprescribers
ofdrugsmaywellobviatetheneedforaBTCclassofdrugs.
FEDERALOTCDRUGSREQUIRINGPRESCRIPTIONSINWASHINGTON.Washingtonstatue(RCW69.41.075)gives
thePharmacyCommissiontorequireprescriptionsforsomedrugsthatareotherwiseOTCunderfederallaw.
EPHEDRINE.TheCommissionhasclassifiedfederalOTCephedrinecontainingproductsasprescriptiononlyin
Washington(WAC246883030).TheruleexemptscertainOTCcombinationbronchodilatorproductscontaining
25mgorlessofephedrine(e.g.,Tedral,Bronitin).Subsequently,theFDAhasproposedtoreclassifyephedrine
combinationsasnotGRASEforOTCuse.201TheFDAcontinuestoallowmarketingofsingleingredient
bronchodilatorproductscontainingephedrine,buttheseproductswillremainprescriptiononlyinWashington.
THEOPHYLLINE.In1992,theCommissionalsoclassifiedalltheophyllinecontainingproductsasprescriptiononly,
exemptingOTCcombinationproductscontaining130mgorlessoftheophyllineperdose.Thesecombinations
wereremovedfromfederalapprovalin1995.
REGULATIONOFBIOLOGICDRUGSANDTHERAPEUTICBIOLOGICALPRODUCTS.CBERANDCDERaretwoFDA
Centersthatreviewandapproveapplicationsfornewdrugsordevices.
CBER(theCenterforBiologicsEvaluationandResearch)regulates:
Allergenicsallergenpatchtestsandallergenicextracts
Bloodandbloodproductsblood,bloodcomponents,bloodbankdevices,andblooddonorscreening
tests
Tissueandtissueproductsbone,skin,corneas,ligaments,tendons,stemcells,sperm,andheartvalves
Vaccinesandtuberculintests
Xenotransplantationtransplantationofnonhumancells,tissues,ororgansintoahuman
118
CDER(theCenterforDrugEvaluationandResearch),inadditiontoregulatingsmallmoleculetherapeuticdrugs,
tests,anddevices,dealswiththerapeuticbiologicapplicationsforthefollowingtypesofproducts:
Monoclonalantibodiesforinvivouse
Cytokines,growthfactors,enzymes,immunomodulatorsandthrombolytics
Proteinsintendedfortherapeuticusethatareextractedfromanimalsormicroorganisms,including
recombinantversions(exceptclottingfactors)
Othernonvaccinetherapeuticimmunotherapies
BIOLOGICLICENSEAPPLICATION(BLA).WhereasmostdrugsareregulatedundertheFDCA,biologicsaresubject
tothePublicHealthServiceAct.TheActrequiresafirmwhomanufacturesabiologicforinterstatesaletoholda
licensefortheproduct.ThesemanufacturerssubmitaBiologicsLicenseApplication(BLA)toFDAinlieuofan
NDA.BiologicproductsevaluatedbyCDERaresubjecttotheprovisionsofPDUFAandsponsorsmustpaythe
applicableuserfee.
BIOSIMILARANDINTERCHANGEABLEBIOLOGICALPRODUCTSarethegenericequivalentsofbiological
products.Thesearealsoknownasfollowonbiologics.Until2010,therewasnostatutoryroutetoallowing
licensingofdrugsthatweresimilarorinterchangeablewithexistingbiologicdrugs,exceptforthefollowon
manufacturertosubmitaBLA.InMarch2010,PresidentObamasignedtheBiologicsPriceCompetitionand
InnovationAct(BPCIAct)202,whichamendedthePublicHealthServicesActtoprovideapathwayforapprovalof
followonbiologicalinamannernotunliketheWaxmanHatchamendmentsdidforgenericdrugs.However,the
BPCIAallowsforgreatervariationincertainareasbetweenthebiosimilarandthereferenceproduct.
Applicationstomarketabiosimilararebecomingcalled351(k)applications,becausetheyareallowedunder
351(k)ofthePHS.Suchanapplicationmustdemonstratethat(1)theproposedbiologicproductishighly
similartothereferenceproductnotwithstandingminordifferencesinclinicallyinactivecomponentsand(2)
therearenoclinicallymeaningfuldifferencesbetweenthebiologicalproductandthereferenceproductin
termsofsafety,purity,andpotency.
OnFebruary15,2012,theFDAdistributedaproposedDraftGuidanceforIndustryonBiosimilars,which
suggestshowFDAwillimplementtheprovisionsoftheBPCIAct.203AlsoinFebruary2012,FDApublisheddraft
guidancesonScientificConsiderationsinDemonstratingBiosimilaritytoaReferenceProduct204andonQuality
ConsiderationsforDemonstratingBiosimilaritytoaReferenceProteinProduct.205
Biosimilaruserfees.TheBPCIArequiredFDAtoinvestigateandreporttoCongressonitsplanandgoalsfor
reviewingbiosimilarbioproductapplications,andcalledonCongresstoauthorizeaprogramstartingin2012for
thecollectionofuserfees.ThisprogramwasauthorizedinsectionIVofFDASIAastheBiosimilarUserFeeActof
2012.
Biosimilarlabeling.InJanuary2017,theFDAissuedaguidanceonnonproprietarylabelingforbiosimilar
drugs.206Seebelow.
The2015LegislatureamendedWashingtonlawtoallowforinterchangeofbiosimilardrugsthatareonalisting
providedbytheFDA.207
STATEREGULATIONOFFOOD,DRUGSANDCOSMETICS.Statesgenerallyhaveadopteda
regulatoryschemethatparallelsthefederalapproach.Washingtonstatutesimplementingthisschemeinclude
thefollowingacts.
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WILLIAME.FASSETT
INTRASTATECOMMERCEINFOOD,DRUGSANDCOSMETICS(formerlytheUniformFood,DrugandCosmetic
ActRCW69.04).ThisistheFDCAforWashington,whichdefines,asdoesthefederallaw,misbrandingand
adulteration,andrequiresthatdrugsregulatedunderthefederallawmustconformtothatlaw.
AdministrationofthelawisvestedintheDirectoroftheWashingtonStateDepartmentofAgriculture.The
DirectorisDerekSandison.Enforcementandadministrationofallprovisionsofthestatutethatpertaintodrugs
andcosmetics,however,areplacedwiththePharmacyCommission.(RCW69.04.730)Personswishingto
manufacturedrugsinthestatefileapplicationswiththePharmacyCommission
CAUSTICPOISONACTOF1929(RCW69.36).Thisstatuteregulatesthelabelingofspecificcausticproducts
soldforhouseholduseatretail.
DangerouscausticorcorrosivesubstancessubjecttotheActinclude:
HClinconcentrations10%208
H2SO4inconcentrations10%
HNO3inconcentrations5%
Phenolinconcentrations5%
Oxalicacidinconcentrations10%
Aceticacidinconcentrations20%209
Hypochlorousacid(chloric(l)acidHClO)inanypreparationyielding10%chlorine
KOHinpreparationsyielding10%KOH
NaOHinconcentrations10%
AgNO3inconcentrations5%
Ammoniawaterinpreparationsyielding5%NH3
Misbrandingofcoveredcausticpoisonsisdefinedasaretailparcel,package,orcontainerofthecovered
substancesthatdoesnotcontainthefollowing:
Nameofsubstance
Nameandaddressofmanufacturer,packager,seller,ordistributor
ThewordPOISONincontrastingcolorandlettersofatleast24pointsize
Directionsfortreatmentincaseofinjury
Labelingrequirementsdonotapplytoproducts
o soldtopharmacistsfordispensing,compounding,orpreparingprescriptions,
o forusebyorunderthedirectionofaphysician,dentist,orveterinarian
o forusebyachemistinthepracticeorteachingofhisprofession
o foranyindustrialorprofessionaluse
o foruseinanyoftheartsorsciences
Communitypharmacies(particularlyinruralareas)areoftensoughtasasourceforthesechemicals.Thekey
elementhereisthatretailpackagesoftheseproductsmustbelabeledaccordingtotheAct.
POISONSALESANDMANUFACTURING(RCW69.38).Thisactrequiresthatpharmaciesorotherretailersof
specifiedpoisonsmustmaintainapoisonregisterinwhichsalesofspecifiedpoisonsarerecorded.Covered
poisonsinclude:
Arsenicanditspreparations
Cyanide,hydrocyanicacid,andpreparations
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Strychnine
OthersubstancesdesignatedbythePharmacyCommissionnonearecurrentlydesignated
ExcludedproductsincludethoseregulatedundertheCausticPoisonsActof1929(RCW69.04),theLegendDrug
Law(RCW69.41),theControlledSubstancesAct(RCW69.50),thePesticideControlAct(RCW15.58),the
PesticideApplicationAct(RCW17.21),andtheDrugSamplesstatute(RCW69.45).
Nosalescanbemadeofcoveredproductsunlessthesellerissatisfiedastotheidentityofthepurchaserand
thatthesaleisforalawfulpurpose.Theregistermustcontainthedateandtimeofsale,thefullnameandhome
addressofthepurchaser,thekindandquantityofpoisonsold,andthepurposeforwhichthepoisonisbeing
purchased.ThenameandaddressofthepurchasermustbeverifiedbyexaminationofphotoID.Pharmacies
maydispensepoisonsonprescriptionwithoutobtainingapoisondistributorslicense.210
POISONSANDDANGEROUSDRUGS(RCW69.40).Thisstatuteprohibitsplacingpoisonsinedibleproducts,
suchascrackers,biscuit,breadorotheredibleproduct(e.g.,hamburger).Italsoprohibitsdistributingmilk
containingformaldehyde.
POISONINFORMATIONCENTERS(RCW18.76).Thisstatuteestablishedastatewidepoisoninformation
centerprogram.
LEGENDDRUGACT(RCW69.41).Thisistheprincipallawgoverningthesale,prescribing,dispensing,anduse
oflegenddrugs.Itselementsarediscussedthroughoutthistextbookwhereapplicable.
CONTROLLEDSUBSTANCES.ThelawsrelatingtocontrolledsubstancesarediscussedinChapter5:
UNIFORMCONTROLLEDSUBSTANCESACT(RCW69.50).ThisisthestateparalleltothefederalCSA.
PRECURSORSUBSTANCES(RCW69.43).ThissupplementstheControlledSubstancesActbyregulating
thesaleanddistributionofchemicalswhichareusedintheproductionofcontrolledsubstances.
CONTROLLEDSUBSTANCESTHERAPEUTICRESEARCHACT(RCW69.51)
MEDICALMARIJUANA(RCW69.51A)
IMITATIONCONTROLLEDSUBSTANCES(RCW69.52)
USEOFBUILDINGSFORUNLAWFULDRUGS(RCW69.53)
DEATHWITHDIGNITYACT(RCW70.245)
911GOODSAMARITANACT(RCW69.50.315;RCW18.130)
INITIATIVE502MARIJUANA211Thisinitiativewaspassedtostoptreatingadultmarijuanauseasa
crime,andauthorizesthestateliquorcontrolboardtoregulateandtaxmarijuanaforpersons21and
older,andsetsathresholdforDUIrelatedtomarijuana.Itmadeanumberofamendmentstothe
ControlledSubstancesAct(RCW69.50)
OVERTHECOUNTERMEDICATIONS(RCW69.60).Thisstatute,nowsupersededbyfederalregulations,
requiredthatOTCsoliddosageformsbeimprintedwithanidentificationsymbolorcode.Becausefederal
requirements(21CFR206.0110)exemptedcertainproductsthatweresubjecttotheWashingtonAct,the
PharmacyCommissionestablishedbyregulationthatOTCdrugsnotcoveredbyfederalrulescouldnotbe
marketedinWashingtonintheabsenceofacomplyingimprintorBoardexemption.(WAC246885030)
DRUGDEVELOPMENTINTHEUS.ThedevelopmentofnewdrugsintheUnitedStatesfollowsa
multistageprocess.
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WILLIAME.FASSETT
PRECLINICALTESTING,invitroandinanimals.Preclinicaltestingbeginswhenthesponsor(manufacturer)files
withtheFDAofaNOTICEOFINVESTIGATIONALNEWDRUG(IND).Thisallowsthedrugtoshippedininterstate
commerceforpurposesoftesting
CLINICALTESTING.
Beforeadrugmaybemarketedforhumanuse,thesponsormustconduct3phasesoftestinginhumans.
PHASEIasmallnumberofhealthyvolunteerstodeterminepharmacodynamicandpharmacokineticproperties
PHASEIIalimitednumberofpatientswhohavethetargetdisease,todetermineefficacyanddoseresponse.
PHASEIIIlargescaleclinicaltrialsinpatientswiththedisease.Atleasttwoclinicaltrialsmustbeconducted
thataredoubleblindedandplacebocontrolled.
Underthe21stCenturyCuresActtheFDAwillhavefrom2to5yearsafterJanuary2017tomakechangestothe
drugapprovalprocessthatallowforuseofrealworldevidence,novelclinicaltrialdesigns,andpatient
experiencedatainmakingapprovaldecisions.212
FILINGOFANEWDRUGAPPLICATION(NDA).Thisfilingdescribesthedrug,theresultsofpreclinicaland
clinicaltrials,setsforththeproposedlabeling,aRiskManagementPlan,anddescribesmanufacturingand
testingprocesses.IftheNDAisapproved,thedrugmaybemarketed.
POSTMARKETINGSURVEILLANCE(ALSOCALLEDPHASEIV).Onceaproductisreleasedformarketing,the
manufacturermustmaintainrecordsandfileannualreportswhichincludesummariesofadversereactionsand
problemsdiscoveredaftermarketing.Significantproblemsmustbereportedpromptly,whichmayleadto
revisionsinthelabeling.AdditionalclinicaltrialsmayberequiredbyFDAforassessmentofsafetyissues,and
manufacturersmayutilizeadditionalclinicaltrialstoestablishnewindications,ornewroutesorformsof
administration,forcurrentlymarketedproducts.
SUPPLEMENTALNDASarefiledwhenthemanufacturerseeksadditionalindicationsorchangesinthelabeling
orproductionofthedrug.TheseareoftenprecededbyPhaseIVtrials.
CHANGEBEINGEFFECTED(CBE)NOTICE.Labelingchangestoimproveproductsafetymaybemadebyholders
ofNDAsthroughanoticetoFDAofaChangeBeingEffected,orCBE.TheFDAhasproposedchangestoallow
genericmanufacturerswhoholdANDAstousetheCBEprovision,buthasdelayedactionuntilApril2017.
ABBREVIATEDNDAS(ANDA)arefiledbymanufacturerswhowishtomarketgenericversionsofapproved
drugsafterpatentrightsexpire.(Seedrugproductselectionsection.)
NEWDRUGAPPLICATIONSARECLASSIFIEDbytheFDAusingaratingscheme,whichisindicatedininformation
announcingthedrugsapproval.Anumberindicatesthechemicaltypeandaletter(P,S,orO)indicatesthe
priorityassignedtothereview.TheFDAconsiders1P(NewMolecularEntitythatisaPriorityreviewdrug)the
mostimportantkindofnewdrug:213InformationonNDAsisfoundatDrugs@FDA.
122
CHEMICALTYPE REVIEWTYPE
1NewMolecularEntity(NME) PPriorityreviewdrug
2Newsaltoresterofapreviouslyapproveddrug SStandardreviewdrug
3Newdosageform OOrphandrug
4Newcombinationofpreviouslyapproveddrugs
5Newformulationornewmanufacturer
6Newindication[nolongerused]
7DrugalreadymarketedwithoutapprovedNDC
8OTCswitch
9NewindicationsubmittedasdistinctNDA,
consolidatedwithoriginalNDAafterapproval
10NewindicationsubmittedasdistinctNDA,not
consolidated
FOODS
UndertheFDCA,foodmeansarticlesusedforfoodordrinkforman214orotheranimals,chewinggum,and
articlesusedforcomponentsofanysucharticle.(21USC321(f))
TheFDAregulateslabelingoffoods,andhaspowerstoseizefoodsthatareadulteratedormisbranded.Foods
donotrequirepremarketingapproval,althoughcertainfoodadditives(colorings,preservatives,etc.)do.
TheFDAFoodSafetyModernizationActof2010wassignedintolawbyPresidentObamaonJanuary4,2011.
AmongitsmanysweepingreformsisagrantofauthoritytoFDAtoinitiatearecalloffoodsthatpresentsafety
issues.215
COSMETICS
CosmeticsaredefinedundertheFDCAtoinclude(1)articlesintendedtoberubbed,poured,sprinkled,or
sprayedon,introducedinto,orotherwiseappliedtothehumanbodyoranypartthereofforcleansing,
beautifying,promotingattractiveness,oralteringtheappearance,and(2)articlesintendedforuseasa
componentofanysucharticles;exceptthatsuchtermshallnotincludesoap.(21USC321(i))
FDAcontrolovercosmeticsisprimarilyrestrictedtoassuringsafety.TheFDAdoesnotregulateclaimsmadefor
cosmetics.
PRODUCTSWHICHMAKETHERAPEUTICCLAIMSareregulatedasdrugs,orasbothcosmeticsanddrugs.
Examplesincludedandruffshampoos,antiperspirantdeodorants,cosmeticsclaimingsunprotection,and
fluoridetoothpaste.216
CosmeticmanufacturersarenotrequiredtoregisterwithFDA,butmaychoosetodosoundertheVoluntary
CosmeticRegistrationProgram(VCRP).217
123
WILLIAME.FASSETT
MEDICALDEVICES
TheFDCAdefinesdevicesasfollows:
Theterm''device''meansaninstrument,apparatus,implement,machine,contrivance,implant,invitro
reagent,orothersimilarorrelatedarticle,includinganycomponent,part,oraccessory,whichis
recognizedintheofficialNationalFormulary,ortheUnitedStatesPharmacopeia,oranysupplementto
them,
intendedforuseinthediagnosisofdiseaseorotherconditions,orinthecure,mitigation,treatment,or
preventionofdisease,inmanorotheranimals,or
intendedtoaffectthestructureoranyfunctionofthebodyofmanorotheranimals,andwhichdoes
notachieveitsprimaryintendedpurposesthroughchemicalactionwithinoronthebodyofmanor
otheranimalsandwhichisnotdependentuponbeingmetabolizedfortheachievementofitsprimary
intendedpurposes.(21USC321(h))[Note:theequivalentdefinitionsinWashingtonsstatuteswere
revisedin2009toreplacemanwithhumanbeings.218]
MEDICALDEVICEAMENDMENTS.SignificantauthorityovermedicaldeviceswasgrantedtotheFDAin
1976,withthepassageoftheMedicalDeviceAmendments.Thepublicityconcerningdeathsandinjuriesfrom
theDalkonShield219intrauterinedeviceisconsideredoneofthefactorsleadingtothepassageofthese
amendments.TheproblemswiththeDalkonShieldledtothebankruptcyoftheA.H.RobinsCo.,formerlyoneof
Americasmostrespecteddrugfirms,andtheoutcomesofthesecondlargestclassactionlawsuit(after
asbestos)inAmericanhistoryarestillunfolding.
The21stCenturyCuresActincludesseveralamendmentstothemedicaldevicerequirements,includingeasing
reportingrequirementsforcertainclassIandclassIIdevices,andimprovementstotherequirementsfor
obtainingCLIAwaiversforofficebasedlaboratorytests.(Seebelow)
DEVICECLASSIFICATIONS.TheDeviceAmendmentsmodifiedtheFDCAtoprovide,amongotherprovisions,the
followingclassificationofdevices:220
CLASSICommonandsimpledevicesneedingtoconformtogeneralstandards(e.g.,tongue
depressors,bandages,neckbraces)
CLASSIIDevicesneedingtomeetspecificperformancestandards(e.g.,thermometers)
CLASSIIIDevicesthatposeriskofinjuryifnotproperlyusedorproduced,thatrequirepremarket
approval(e.g.,defibrillators,pacemakers,IUDs,laboratorytests)
RESTRICTEDDEVICES.Somedevicesrequireaprescriptionororderofaprescribertosellordispense.Theseare
labeledCaution:Federallawrestrictsthisdevicetosalebyorontheorderofaphysician.
SYRINGESANDNEEDLES.Syringesandneedlesarenotrestricteddevicesunderfederallaw.However,
manystatesplacerestrictionsonthesaleofinjectiondevices,andmayrequireaprescriptionbeforea
pharmacistmaymakeasale.
NEEDLEEXCHANGEPROGRAMSARELEGALINWASHINGTON.PHARMACISTSMAYSELLSYRINGESANDNEEDLES
TOADULTIVDRUGUSERS.Washingtonlawallowspharmaciststosellneedlesandsyringeswithout
prescription,subjecttotherequirementthatOnthesaleatretailofanyhypodermicsyringe,hypodermic
needle,oranydeviceadaptedfortheuseofdrugsbyinjection,theretailershallsatisfyhimselforherselfthat
thedevicewillbeusedforthelegaluseintended.(RCW70.115.050)SHB1759,passedin2002,modifiedthe
statesdrugparaphernalialaw,andaddedthefollowingprovisions:
124
Makingitlawfulforanypersonovertheageofeighteentopossesssterilehypodermicsyringesand
needlesforthepurposeofreducingbloodbornediseases(RCW69.50.412(5)).
SpecifyingthatnothingintheDrugParaphernaliaActprohibitslegaldistributionofinjectionsyringe
equipmentthroughpublichealthandcommunitybasedHIVpreventionprograms,andpharmacies.
(RCW69.50.412(3))
SpecifyingthatNothingcontainedin[theDrugParaphernaliaAct]shallbeconstruedtorequirea
retailertosellhypodermicneedlesorsyringestoanyperson.(RCW70.115.060)
Undertheseprovisions,needleexchangeprogramsarelegalinWashington,andpharmacistsmaysellsyringes
andneedlestopersonsovertheageofeighteen,evenifthosepersonsarebelievedtobeusingthedevicesto
injectillegaldrugs,providingthatthepurposeofthesaleistopreventspreadofbloodbornepathogens,suchas
HIV,HBV,orHCV.
Asummaryofstatelawsregulatingsyringesalesisavailableontheinternetat
http://www.temple.edu/lawschool/phrhcs/otc.htm.TheJournaloftheAmericanPharmaceuticalAssociation
devotedaspecialissuetosyringelawsandaccesstosyringesin2002(NovDec;42(6Suppl2)).
POSSESSIONOFTRACESOFCONTROLLEDSUBSTANCESILLEGAL.AlthoughitislegalforanIVdrugusertopossess
syringesandneedles,controlledsubstanceresidueinthesyringemaystillbeusedasevidenceofillegal
possessionofcontrolleddrugs.UnderWashingtonlaw,unlawfulpossessionofevenatraceamountof
controlledsubstanceispunishablebyupto5yearsinprison,afineofupto$10,000,orboth(RCW69.50.140(d),
Statev.Malone,864P.2d990(Wash.App.Div.1994)).
LABORATORYTESTS.Clinicallaboratorytestsareregulatedasdevices,andgenerallymustbeperformedin
aqualifiedclinicallaboratoryregisteredundertheClinicalLaboratoryImprovementAmendments(CLIA).221
Laboratoriesmustmeetrequirementsforcalibrationoftests,qualityandtrainingofpersonnel,proficiency
testing,recordsandspecimenretention,qualityassurance,andotherrequirementsforGoodLaboratory
Procedures.Pharmacistsandotherhealthprofessionalsperformingpointofcarebasedlaboratorytestsmust
obtainawaiverfromtheserequirements,whichiscalledaCLIAWaiver.Thisallowsthemtoperformtestsusing
certainlaboratorytestingdevicesthathavealsobeencertifiedbytheFDAasCLIAwaiveddevices.Inmany
states,theCLIAwaiverforahealthprofessionalisobtainedfromtheCMSwebsite222usingfederalformCMS
116,butinWashington,CLIAwaiversareobtainedfromtheDepartmentofHealthsLaboratoryQuality
AssuranceProgram.223
MERCURYCONTAININGDEVICES.Concernswiththebuildupofmercuryintheenvironmentledthe
Legislaturein2006toprohibitthesaleofthermostatsandotherdevicescontainingmercury,includingmedical
thermometersandmanometers.Exceptionsare:
Prescribedthermometers,suchaslowtemperaturereadingdevicesorbasaltemperature
thermometers;
Electronicthermometerswithmercurycontainingbatteries;
Thermometersormanometersusedtocalibrateotherdevices;
Devicessoldtohospitalsorhospitalcontrolledhealthcarefacilitiesthathaveadoptedaplanfor
mercuryreductioninaccordancewithstatelaw.(RCW70.95M.050)
AdditionalinformationisavailablefromtheDOH,224andfromtheDepartmentofEcology.225
125
WILLIAME.FASSETT
ANIMALDRUGS
Thistextbook,unlessotherwisespecified,discussesdrugsforuseinhumans.TheFDAalsoregulatesdrugsused
totreatotheranimalspecies,andshareswiththeDepartmentofAgricultureresponsibilityfordrugsandother
chemicalsusedinanimalfeedorintheproductionoffoods.TheFDCAmakesadistinctionbetweenanew
drugandanewanimaldrugandenforcesspecificregulationsforbothtypesofdrugs.Ingeneral,
veterinariansmayprescribehumandrugsforanimals,andpharmaciesmayfillthem.Itshouldbenotedthat
manyhumandrugsaretoxictospecificspecies,suchaslincomycinsgastrointestinaltoxicityinhorses,and
otherdrugsarelesstoxicinotheranimalspeciesthaninhumans,suchaschloramphenicolindogs.Animaldrugs
maynotbeusedinhumans,andtherearespeciesspecificrestrictionsontheiruseinotheranimals.Also,
animaldrugsusedinfeedmayposeenvironmentalandotherdangers,andthereareanumberofanimaldrugs
thatmaynotbeadministeredinfeed.Theregulationsalsotreatnonfoodanimals(e.g.,catsanddogs)
differentlyfromanimalsintendedforhumanfood(e.g.,cattle,pigs,chickens,etc.).Veterinariansincreasingly
refertopetsascompanionanimals,whosepropercareisworthwhileinitself,butfrequentlyimportanttothe
healthoftheirhumancompanionsaswell.
TheFDAsCenterforVeterinaryMedicine226administerstheFDCAasitpertainstodrugsusedinanimalsandin
animalfeed.TheveterinaryequivalenttotheOrangeBookistheGreenBook227(FDAApprovedAnimalDrug
Products).
Tworecentlawsareofinteresttopharmacistsinvolvedinveterinarypharmacyorinsupplyingdrugsto
veterinarians.
THEANIMALMEDICINALDRUGUSECLARIFICATIONACTOF1994(AMDUCA),whichprovides
forveterinarianprescribingofextralabeldruguse(ELDU)fornonfoodanimals.
THEMINORUSESANDMINORSPECIESHEALTHACTOF2004(MUMS),whichprovidesfor
legaluseofnonapproveddrugsinminoranimalspeciessuchasornamentalfishanduncommondiseasesin
majorspecies.
Manypharmacistsareinvolvedincompoundingdrugsforuseinanimals,withcreatingflavoreddosageforms
forcompanioncatsbeingaparticularlysignificantactivity.TheFDAhasattemptedtoenforceitsviewthat
AMDUCAprohibitscompoundinganimaldrugsfrombulkingredients,andsoughtaninjunctionagainstaFlorida
pharmacy.ThefederaldistrictcourtruledagainstFDA,holdingthatitsCompliancePolicyGuideonanimal
compoundingwascontrarytopriorenforcementandwasnotthesubjectofnoticeandcommentrule
making.228(Seecompounding)Thegovernmentandthepharmacyultimatelyreachedasettlementfollowingthe
suitandjointlymovedtovacatethedecisionasmoot,whichwasgranted.So,althoughtheCourtfoundagainst
theFDA,itsdecisionisnolongerinforce.229
TheDrugQualityandSecurityActof2013clarifiedthatpharmaciescompoundingforanimalspursuantto
prescriptionsfromaveterinarianareexemptfromcertainAMDUCArequirements.
DRUGSGENERALLY
TheFDCAwasenactedin1938,atatimewhentheconceptofprescriptiononlydrugs(otherthannarcotics)was
overadecadeinthefuture.Thus,theoriginalviewoftheActwasthatalldrugswouldbemarketedonlyifthe
manufacturercouldshowtheyweresafeforusebyhumansinaccordancewiththelabelingthatwouldbe
126
availabletotheuserorconsumer.Aswith
othercategoriesofarticlesregulatedunder FDCADEFINITIONOFDRUG
theAct,whetherasubstanceisadrug 21USC321(g)(1)Theterm''drug''means
dependsonitsINTENDEDUSE. (A)articlesrecognizedintheofficialUnitedStates
Pharmacopoeia,officialHomoeopathicPharmacopoeiaofthe
Forexample,earlierwesawthatwhetheran UnitedStates,orofficialNationalFormulary,orany
articlewasadevicedependsinparton supplementtoanyofthem;and
whetheritisintendedtodiagnoseortreat (B)articlesINTENDEDFORUSEINTHEDIAGNOSIS,CURE,
conditionsinhumansoranimals,andforan MITIGATION,TREATMENT,ORPREVENTIONOFDISEASEIN
articletobeacosmeticrequiredthatitbe MAN*OROTHERANIMALS;and
intendedonlyforapplicationtotheskinto (C)articles(otherthanfood)intendedtoaffectthestructure
cleanseorbeautify.Drugsdifferfrom oranyfunctionofthebodyofman*orotheranimals;and
devicesinthattheydependuponsomeform (D)articlesintendedforuseasacomponentofanyarticle
ofchemicalactiontoaffectbodyfunction. specifiedinclause(A),(B),or(C).Afoodordietary
supplementforwhichaclaim,subjecttosections343(r)(1)(B)
AsaresultofthehistoryoftheFDCA,there
aretwomajortypesofdrugsthatare and343(r)(3)ofthistitleorsections343(r)(1)(B)and
343(r)(5)(D)ofthistitle,ismadeinaccordancewiththe
regulateddifferentlybasedonwhetherthey
maybesolddirectlytothegeneralpublicor requirementsofsection343(r)ofthistitleisnotadrugsolely
becausethelabelorthelabelingcontainssuchaclaim.A
requireaprescription.However,alldrugs
food,dietaryingredient,ordietarysupplementforwhicha
mustmeetthetestsintheFDCAofSAFETY,
truthfulandnotmisleadingstatementismadeinaccordance
EFFECTIVENESS,andfreedomfrom withsection343(r)(6)ofthistitleisnotadrugunderclause
ADULTERATIONorMISBRANDING. (C)solelybecausethelabelorthelabelingcontainssucha
statement.
*Asnotedabove,equivalentWashingtondefinitionsofdrughave
NONPRESCRIPTION(OTC) beenamendedtoreplacemanwithhumanbeings.
DRUGS
ADULTERATIONANDMISBRANDING
The1938ActretainedtwokeyrequirementsformarketingofdrugsintheUSthatwereintheWileyLaw:they
mayneitherbeadulteratednormisbranded.Drugsthatfaileitheroftheserequirementsmaybeseizedand
removedfromthemarketplacebytheFDA,andmarketersorsellersoftheproductsmaybesubjecttocriminal
orcivilpenalties.
ADULTERATION.AdrugisadulteratedifitCONTAINSANYADDEDDELETERIOUSSUBSTANCES,HASBEENSTORED
IMPROPERLY,ORISPACKAGEDINSUCHAWAYASTOALLOWDETERIORATION.(21USC351)
Anyarticlelistedintheofficialcompendium(i.e.,theUSP/NF)mustconformtocompendialstandardsforpurity,
quality,strength,andappropriateassays.
DrugsmustbestoredinaccordancewithUSPstandards,andanyspecialrequirementsspecifiedonthe
manufacturerslabel.
TheUSPdefinesthefollowingtemperaturerangesforstoringdrugs:
Controlledroomtemperature68Fto77F(20Cto25C),subjecttorequirementsforthemaximum
meankinetictemperatureandlimitedexcursionsandspikes.
Coolplacebetween46Fand59F(8Cand15C)
127
WILLIAME.FASSETT
Coldplacearefrigerator,between36Fand46F(2Cto8C)
Freezeraplacemaintainedbetween13Fand14F(25Cto10C)
Pharmaciesmustmaintaintheirdrugstorageareaswithinacontrolledrange,whichrequiresairconditioningin
mostareasoftheUS.Refrigeratorsorfreezersusedtostoredrugsmaynotbeusedtostorefoodornondrug
products.
MISBRANDING.AdrugismisbrandedifitsLABELINGISINCOMPLETEORMISLEADING.RepackaginganOTCdrug
withoutsupplyingalltheinformationcontainedontheoriginalbottleisaformofmisbranding.(21USC352)
TheLABELofadrugistheactuallabelaffixedtothebottleorboxcontainingthemedication.TheLABELING
includesthelabel,andanyotherprintedorwrittenmaterialaccompanyingthedrug.Labelingalsoincludes
statementsmadebythemanufactureorsellerinpromotionalmaterials,advertisements,orother
communicationstopatientsorhealthprofessionals.
OTCdrugsmustbearadequatedirectionssothatlaypersonscanusetheproductsafelyandeffectively.Ifa
productcannotbelabeledinsuchawaythattheconsumercanuseitjustbyreadingthelabel,itwillbe
restrictedtosalebyprescription.
REQUIREDOTCLABELING.SpecificelementsarerequiredbytheFDCAonthelabelsofOTCdrugs.The7
pointlabelmustcontain:
NameofProduct
Nameandaddressofmanufacturer,packager,distributor
Netcontents
Activeingredientsandquantityofcertainotheringredients
Nameofanyhabitformingdrug
Cautionsandwarnings
Adequatedirectionsforuse
STANDARDIZEDDRUGFACTSOTCLABELS.TheFDAdevelopedregulations230in1999thatchangedthelook
ofOTCdruglabelsandrequirethesameformatforalllabels.InformationabouttheOTCproductmustbein
plainlanguageandprovidethefollowingintheorder
shown:
Theproduct'sactiveingredients,includingtheamountin
eachdosageunit.
Thepurposeoftheproduct.
Theuses(indications)fortheproduct.
Specificwarnings,includingwhentheproductshouldnot
beusedunderanycircumstances,andwhenitis
appropriatetoconsultwithadoctororpharmacist.This
sectionalsodescribessideeffectsthatcouldoccurand
substancesoractivitiestoavoid.
Dosageinstructionswhen,how,andhowoftentotakethe
product.
128
Theproduct'sinactiveingredients,importantinformationtohelpconsumersavoidingredientsthatmaycause
anallergicreaction.
IMPRINTSREQUIREDONSOLIDORALDOSAGEFORMS.WashingtonrequiresthatallOTCsolidoral
dosageformssoldinthestatemustbeimprintedwithadistinctivesymbolorcode.(RCW69.60)Subsequent
FDAregulations(21CFR206)requireimprintsonvirtuallyallUSOTCproducts.
ENGLISHLANGUAGEREQUIRED.AllrequiredlabelelementsmustbeinEnglish(CFR201.15(c)(1)).This
requirementisimplementedinWAregulationsinWAC246869150(4).
SPANISHSPEAKINGUSTERRITORIES.However,drugsdistributedinPuertoRico,oraUSTerritorywherethe
predominantlanguageisotherthanEnglish,thelabelelementsmaybeinthepredominantlanguage.(CFR
201.15(c)(1)DrugslabeledinEnglishthatincludeanyrepresentationsinthelabelorlabelinginaforeign
language(e.g.,SpanishorFrench)mustalsoincludealltheotherrequiredinformationinthesameforeign
language(CFR201.15(c)(2,3).
TheWashingtonPharmacyCommissionhaschargedapharmacistwithviolatingtheserequirementswhena
Europeanherbalproduct,DoktorMom,whichislabeledinUkrainianbutwithingredientsdescribedusing
Linnaeannomenclature,wassoldtoaRussianspeakingconsumerallegedlywithoutanysupplementallabeling
inEnglish.
POISONPREVENTIONPACKAGING.SelectedOTC
productsmustbepackagedinspecialpackaging, POISONPREVENTIONPACKAGING
otherwiseknownaschildresistantcontainers(CRCs),as NOTREQUIREDFORMOSTOTC
requiredbythePoisonPreventionPackagingAct(15USC
PRODUCTS,withspecificexceptions
14711474).Regulationsimplementingtheactare
developedbytheConsumerProductSafetyCommission, REQUIREDFORMOSTRXPRODUCTS,
whichpublishesPoisonPreventionPackaging:AGuidefor withsomeexceptions
HealthcareProfessionals.231Rulesfornonprescription
drugsarecontainedin16CFR1700.14.
OTCDRUGSREQUIRINGCHILDRESISTANTCONTAINERSinclude:
ASPIRIN(ASA)ORACETAMINOPHEN(APAP):anyformulationcontainingASAinanyamountor
containingAPAP>1g/package.
Exceptions:Effervescenttablets/granules15%ASAorAPAP,iftheoralLD50ofthegranules5g/Kgor
unflavoredAPAPorASAcontainingpowders(notintendedforpediatricuse)packagedinunitdoses
providing13grainsAPAPor15.4grainsASAperunitdose.(Whatwouldthesequantitiesbein
milligrams?)
NSAIDS:Ibuprofen>1g/package;Naproxen>250mg/package;Ketoprofen>50mg/package
IRONpreparations(includingdietarysupplements)>250mgelementalironperpackage
DIPHENHYDRAMINE>66mg/package
FLUORIDE>50mgfluorideion(F)/packageor>0.5%w/voffluorideion
LIDOCAINE>5mg/packageorDIBUCAINE>0.5mg/package
LOPERAMIDE>0.045mg/package
MINOXIDIL>14mg/package
METHACRYLICACID(inliquidbandage)>5%w/v
METHYLSALICYLATEanyquantity
129
WILLIAME.FASSETT
ETHYLENEGLYCOLanyquantity
METHYLALCOHOLanyquantity
MOUTHWASHcontaining3gormoreethanol/package;howeverapumpcontainerwithnonremovable
pump,containing7%w/wormorecinnamonormintflavoring,and<15gofethanolpercontainer,and
dispensing<0.03gofethanolperpumpisexempt.
HYDROCARBONS,SOLVENTS,HOUSEHOLDFUELS;drugsandcosmeticscontaininglowviscosity
hydrocarbons(e.g.,certainlightmineraloil,NF)
NAOH,KOHanyquantity
H2SO4anyquantity
PERMANENTWAVENEUTRALIZERS(>600mgNaBrO3or>50mgKBrO3)
PREVIOUSRXONLYPRODUCTSotherOTCscontaininganyactiveingredientthatwaspreviously
availablefororaladministrationonlybyprescription(e.g.,omeprazole,ranitidine)
OTCCONTROLLEDSUBSTANCESanyquantity
LIQUIDNICOTINEPRODUCTSaddedtothePPPArequirementsbytheChildNicotinePoisoning
PreventionActof2015.232Certainformsofpackagingforecigaretterefillsmaybeexempted.
PACKAGESFORHOUSEHOLDSWITHOUTSMALLCHILDREN.ForOTCdrugs,eachmanufacturermustmakeat
leastonepackagesizewithaCRC.Amanufacturermaymakeonesizeonlythatisintendedforhouseholds
withoutsmallchildren.ItmustbearthecautionThisPackageforHouseholdswithoutYoungChildren.For
smallpackages,themanufacturermaysubstitutethewording,PackageNotChildResistant.
DISPENSINGCOVEREDOTCSBYPRESCRIPTION.Washingtonlawrequirespharmacistswhodispenseanyofthe
abovelistedOTCdrugsonprescriptiontouseaCRC.(RCW18.64.246andWAC246869230)Theseregulations
canbereadtorequireCRCsonallprescriptionsinwhichOTCdrugsaredispensed,eveniftheCPSChasnot
listedtheproduct,butinatleastonestatecourtcasethejudgeruledtothecontrary.
PREVENTINGPRODUCTTAMPERING.Problemswithproducttamperinghaveledtorequirementsin
the1983FederalAntiTamperingAct(18USC1365).MostOTCdrugs,devices,andcosmeticsrequirethe
followingelements(dentifrices,dermatologicals,lozenges,andinsulinareexempted):
Anindicatoroftamperingorbarriertoentry,that
Ifbreachedormissingprovidesvisibleevidenceoftampering;and
Alabelstatementmustdescribethebarrierorindicator.
AnOTCproductthatisonapharmacyshelfwhosepackagingisdamagedisMISBRANDEDandinviolationofthe
antitamperingact.Theresponsiblepharmacistmanagerwithinthestoremaybeheldliablefornotassuring
thatsuchproductsareremovedfromtheshelves,eveninestablishmentswherethepharmacistdoesntstockor
orderOTCproducts.
RECALLSOFOTCPRODUCTSarehandledinthesamemannerasforlegenddrugs(seebelow).
UNLABELEDUSESOFOTCDRUGS.Sellersareresponsibleforanyfalse,misleading,orunapproved
claimstheyortheiremployeesmakeconcerningOTCproductsthatarenotconsistentwiththeapproved
labeling.Pharmacistsareallowedtomakerecommendationstocustomersaboutthehazardsandbenefitsof
medications,consistentwiththeirknowledge,training,experience,andgoodjudgment.Specificassurances
(thisisperfectlysafeforyourbaby)maycreateawarrantyoffitnessforaparticularpurchasethatcanleadto
liabilitytotheconsumeriftheproductdoesnotperformasstatedorisharmful(seeChapter7).
130
CONTROLLEDOTCSUBSTANCES(seealsoChapter5).
TheControlledSubstancesActpermitsthesaleofcertainproductswithoutaprescription.However,unlikemost
otherOTCproducts,theseproductsmayonlybesoldbypharmacistspursuanttostateandfederallaws.
METHAMPHETAMINEPRECURSORCONTAININGPRODUCTS
Atvarioustimesithasbeenpermissibletosellcoughandcoldordietcontrolpreparationscontaining
ephedrine,phenylpropanolamine(PPA),orpseudoephedrineasOTCformulations.Eachoftheseingredientshas
beenasourceofillegalproductionofmethamphetamine.
PPAwasfoundtobeassociatedinOTCdosesof75mgorgreaterwithincreasedriskofhemorrhagicstroke,
andtheFDArequestedallmanufacturerstovoluntarilyrecallPPAcontainingOTCproductsinNovember,2000.
OnDecember22,2005,theFDApublishedaproposedfinalrulethatwouldpermanentlyplaceOTCformulations
ofPPAinCategoryII,i.e.,notapprovedforuseOTC,andhasestablisheda90daycommentperiod.(70FR
7598898,December22,2005.)
DrugproductscontainingEPHEDRAoritsalkaloidsmaynotbepromotedforweightloss,enhancementof
athleticperformance,orasstimulants.InJuly2005,theFDApublishedaproposedfinalruleallowingthe
continueduseofephedrinealkaloidswithenhancedwarningsandlabelrequirements(70FR4023749,July13,
2005).Subsequently,theFDAhasproposedtoreclassifyephedrinecombinationsasnotGRASEforOTCuse,233
butwillcontinuetoallowsingleingredientproducts.Certainephedrinesaltsmaybeusedinophthalmic
preparationsornasalspraysandinrectalproductsusedtotreathemorrhoids;inallcasesastopical
vasoconstrictor.Singleingredientephedrine/ephedraproductsarefurtherrestrictedtosalebehindthecounter
byDEArules(seeChapter5).Washingtonlawclassifiesallephedrinecontainingproducts,exceptcertain
combinationswhichhavebeenremovedfromthemarket,asprescriptiononlydrugs.
Pseudoephedrinecontainingproductsarenowrestrictedbybothfederalandstatelawswhichlimitthequantity
thatcanbesoldatanyonetimeand/orrequiretheproducttobekeptbehindthecounter.(SeealsoChapter5)
Manufacturersarereformulatingmanynasaldecongestantproductswithphenylephrinetoallowtheirbrandto
becontinuedtobesoldwithoutrestriction.
NONPHARMACYSALESOFOTCDRUGS.Therequirementthatpharmaciesmustbeownedby
pharmacistsgainedacceptanceearlyinthe20thcentury,butwaslaterabandonedinmoststates.AUSSupreme
Courtdecisionin1928(LiggettvBaldridge,278US105(1928))overturnedstatelawsrestrictingownershipof
pharmaciesandwasseenasbindinguntil1973,whentheSupremeCourtreverseditsdecisioninLiggettand
allowedstatelegislaturestherighttopasssuchlaws(NorthDakotaBoardofPharmacyvSnydersDrugStores,
Inc.,414US156(1973)).Fewstatelegislatureshavechosentorestrictownershipofpharmaciestopharmacists,
insteadtorequirethataregisteredpharmacistbeplacedinchargeofeverypharmacy.Atthesametime,states
allowOTCstobesoldinnonpharmacyoutlets.Moststatesrequireregistrationofthesesellers,asdoes
Washington,wheretheymustberegisteredasShopkeepersorItinerantVendors(seeChapter3).
DIETARYSUPPLEMENTS
DietarysupplementsareregulatedbytheDietarySupplementHealthandEducationActof1994(DSHEA).The
Actwaspassedtoallowcertainhealthrelatedclaimstobemadefordietarysupplementswithoutviolatingthe
FDCAorcausingthesupplementstoberegulatedasiftheyweredrugs.
131
WILLIAME.FASSETT
DIETARYSUPPLEMENTSaredefinedundertheDSHEAasarticlescontainingoneormoreofthefollowing:
VITAMIN,MINERAL,HERBorotherbotanical,orAMINOACID.
Tobeconsidereddietarysupplements,aproductmustbe
INTENDEDTOSUPPLEMENTTHEDIETBYINCREASINGTOTALDIETARYINTAKEOFTHEABOVE,ORA
CONCENTRATE,EXTRACT,METABOLITE,CONSTITUENTORCOMBINATIONOFTHEABOVE.
INTENDEDFORINGESTION
NOTREPRESENTEDFORUSEASACONVENTIONALFOODORSOLEITEMOFAMEALORDIET
LABELEDASADIETARYSUPPLEMENT
Ifthearticlemeetsalloftheaboverequirements,itisdeemedtobeaFOOD,andisregulatedbytheFDAasa
food,subjecttosomespecificlabelingrequirements.
ALLOWABLELABELINGforadietarysupplementcan
ClaimbenefitrelatedtoaCLASSICNUTRITIONALDEFICIENCYDISEASE(e.g.,scurvy,beriberi)
DESCRIBETHEROLEofanutrientintendedtoaffectthestructureorfunctionofthebody
CharacterizetheMECHANISMOFACTION
DescribeGENERALWELLBEINGgainedfromconsuminganutrient
MuststatethattheFDAHASNOTEVALUATEDanylabelingclaims
TheFDAcantakeactionagainstfalsestatements,adulteratedormisbrandedproducts,orremovefrommarket
productsthatareshowntobeharmful.Dietarysupplementscontainingephedraorephedrinealkaloids
(ephedrine,ephedrineHCl,ephedrinesulfate,andracephedrineHCl)werebannedintheUSbyFDArulemaking
inFebruary2004(69FR67886853)thatdeclaredsuchproductsadulterated(21CFR119).
SELLERSMAYNOTADDPROMOTIONALINFORMATIONTHATISNOTALLOWEDINLABELING.Sellers(suchas
pharmacies)ofdietarysupplementsmaynotjuxtaposenoncomplyingmaterial(books,advertisements,etc.)
withdietarysupplementsinsuchawayastomakehealthclaimsnotallowedinthelabeling.Sellersmaysellor
displayarticles,books,andabstractsofpeerreviewedscientificpublications.However,anysuchbooks,etc.,
mustbereprintedintheirentirety,mustbepresentedwithotherpublicationstopresentabalancedview,and
mustbephysicallyseparatefromtheproduct.Sellersmaynotapplyinformationtotheproductbysticker,
shelftalker,etc.,thatwouldmakeclaimsnotallowedinlabeling.
CONSUMERPRODUCTSADVERTISING
RegulationofadvertisingofproductssolddirectlytoconsumersisplacedundertheauthorityoftheFederal
TradeCommission(FTC);thisincludesOTCdrugs,homeopathicproducts,anddietarysupplements.TheFTC
generallysetstruthinadvertisingstandardsthatapplytoallconsumerproducts.Thesestandards,accordingto
theFTC,"canbeboileddowntotwocommonsensepropositions:1)advertisingclaimsmustbetruthfulandnot
misleading;and2)beforedisseminatinganad,advertisersmusthaveadequatesubstantiationforallobjective
productclaims."TheFTCevaluatesclaimsaboutsafetyandefficacyoffoods,dietarysupplements,anddrugs
basedon"competentandreliablescientificevidence."SignificantactionsbyFTCrelatingtoOTChealthclaims
haveincluded:
$30millionsettlementwithmakersofAirborneavitaminCsupplement
132
$2.6millionjudgmentagainstmakersof"ZyladexPlus"the"NewSkinnyPill"
OrderprohibitingNestlHealthcareNutrition,Inc.,frompromotingitsBOOSTKidEssentialsasreducing
durationofacutediarrheainchildrenorreducingabsencesfromschoolordaycareduetoillness
HOMEOPATHICDRUGS.InDecember2016,theFTCannouncedanewenforcementpolicyregardingclaims
madeforhomeopathicremedies.234TheFTCnotedthat"forthevastmajorityofOTChomeopathicdrugs,the
caseforefficacyisbasedsolelyontraditionalhomeopathictheoriesandtherearenovalidstudiesusingcurrent
scientificmethodsshowingtheproduct'sefficacy.Accordingly,marketingclaimsthatsuchhomeopathic
productshaveatherapeuticeffectlackareasonablebasisandarelikelymisleadinginviolationofSections5and
12oftheFTCAct."TheFTCpolicyhasthefollowingelements:
Anadvertisingclaimforahomeopathicproductmaynotbemisleadingifithasaprominentdisclaimer
that"effectivelycommunicatestoconsumersthat(1)Thereisnoscientificevidencethattheproduct
worksand(2)theproduct'sclaimsarebasedonlyontheoriesofhomeopathyfromthe1700sthatare
notacceptedbymostmodernmedicalexperts."
Anydisclaimersshould"standoutandbeincloseproximitytotheefficacymessage"
Marketersshouldnotundercutqualificationswithadditionalpositivestatementsorconsumer
endorsements
Theinherentcontradictioninassertingaproductiseffectiveandyetthereisnoevidenceforsuchan
assertionmaymeanthatthedisclaimerisnoteffective;marketersshouldbeabletodemonstratethat
consumersdounderstandthelimitedproofofanyclaims
IftheFTCfindsthat"despiteamarketer'sdisclosures,anadconveysmoresubstantiationthanthe
marketerhas,themarketerwillbeinviolationoftheFTCAct."
LEGENDDRUGS(PRESCRIPTIONONLYDRUGS)
FDADETERMINESADRUGSSTATUSONACASEBYCASEBASIS.Unlessthedrugcanbe
marketedasanOTCproductinaccordancewiththevariousapprovedmonographs,anewentitywillbe
evaluatedonacasebycasebasistodeterminewhetheritcanbemarketedOTCormustbeprescriptiononly.
WASHINGTONDESIGNATIONOFPRESCRIPTIONONLYDRUGS.Forthepurposesofthestate
LegendDrugAct,thePharmacyCommissionischargedwithdeterminingbyregulationthedrugscoveredbythe
Act.(RCW69.41.010(12)).TheCommissionhastraditionallydonethisbyspecifyinganationallyrecognizedlist
ofdrugsrequiringaprescriptionunderfederallaw,i.e.,theDrugTopicsRedBook.Thecurrentreferenceforthis
purposeisthe2009editionoftheRedBook.235(WAC246883020)
Marketedproductsthatareinfactlegenddrugsunderfederallaw,butnotlistedintheRedBook,mayormay
notconstitutelegenddrugsundertheLegendDrugAct.Thisisusuallyatechnicalissuewhenapersonischarged
withaviolationofRCW69.41.Forpharmacists,however,dispensingsuchaproductwithoutprescriptionwould
violatefederallaw,inanycase,whichisabasisfordiscipline.
WashingtonsIntrastateCommerceinFood,DrugsandCosmeticsAct(RCW69.04)containsanothersourceofa
prescriptiononlyrequirement:Adrugordeviceshallbedeemedtobemisbrandedifitisadrugwhichbylabel
provides,orwhichthefederalactoranyapplicablelawrequiresbylabeltoprovide,ineffect,thatitshallbe
usedonlyupontheprescriptionofaphysician,dentist,orveterinarian,unlessitisdispensedatretailona
writtenprescriptionsignedbyaphysician,dentist,orveterinarian,whoislicensedbylawtoadministersuch
drug.(RCW69.04.540)Thelegislaturehasnotattemptedtoupdatethisstatutetoreflecttheauthorityithas
grantedtootherpractitionerstoprescribelegenddrugs.
133
WILLIAME.FASSETT
RXSYMBOLONLABEL.(FDCA21USC502).Formerly,prescriptiondrugswererequiredtobearthe
legend,Caution:FederalLawprohibitsdispensingwithoutaprescription.NowtheymaymerelybeartheRx
symbol.
BARCODINGREQUIREMENTSFORINSTITUTIONALUSEDRUGS.Althoughmostbulkpackagesof
prescriptiondrugshaveabarcodeonthelabel,unitdoseitemsoftendonot.Thelackofbarcodingon
individualpackagesofprescriptiondrugshashamperedtheimplementationofbarcodescanningsystemsin
hospitals,whichareseenasanessentialelementforimprovingpatientsafety.TheFDAadoptedregulationsin
2004,whichbecameeffectiveinApril2006,requiringcertainhumandrugandbiologicalproductlabelsto
containabarcodeconsistingoftheNDCnumberinareadilyscannedformat.(21CFR201.25)Exemptionscan
besoughtforselectedproducts.Coveredproductsinclude:
Versionsofprescriptiondrugproductsthataresoldtoorusedinhospitals,except:
Prescriptiondrugsamples
Allergenicextracts
IUDstreatedasdrugs
Medicalgases
Radiopharmaceuticals
Lowdensitypolyethylene(LDPE)formfillandsealcontainersnotpackagedwithanoverwrap
Biologicalproducts
OTCproductsthataredispensedpursuanttoanorderandarecommonlyusedinhospitals
PHARMACISTLABELINGOFDISPENSEDPRESCRIPTIONDRUGS.AswithOTCdrugs,alegenddrug
isMISBRANDEDifthelabelingisincompleteormisleading.TheLABELofalegenddrugistheactuallabel
affixedtothebottleorboxcontainingthemedication.TheLABELINGincludesthelabel,andanyotherprinted
orwrittenmaterialaccompanyingthedrug.Labelingalsoincludesstatementsmadebythemanufacturein
promotionalmaterials,advertisements,orothercommunicationstopatientsorhealthprofessionals.Dispensing
alegenddrugpursuanttoaprescriptionwithoutaprescriptionlabelisaformofmisbranding.
LABELSONAMBULATORYPRESCRIPTIONS.Table41summarizesFDCAandstatelawrequirementsforthelabel
ofaprescriptiondispensedbyapharmacisttoapatient.
134

TABLE41.ELEMENTSREQUIREDONAPRESCRIPTIONLABELDISPENSED
TOAPATIENT(AMBULATORYPHARMACY,HOSPITALOUTPATIENT)
RxBottle CustomPackaging
FDCA RCW18.64.246 WAC246869255
Nameandaddressofthe
pharmacy
Aserialnumber
Nameofprescriber
Nameofpatient,ifonthe
prescription
Nameofpatient
Directionsforuse,ifonthe
prescription
Completedirectionsforuse Asdirectedprohibited
(WAC246875020(1)(h))
Dateoffillingorrefilling
Nameandstrengthofdrug *
Quantitydispensed * WAC246869210(2) Max.31daysupply
Anexpirationdate.Often
calledausebeforeor (Seefactorsrequiredin
discardafterdate WAC246869210(1))
ATRANSFERCAUTIONLABEL
containingthestatement, WAC246869210(3)
Warning:StateorFederallaw
prohibitstransferofthisdrug
toanypersonotherthanthe
personforwhomitwas
prescribed
Identityofpharmacist **
responsiblefordispensing.
Supplementedbyadditional
oralorwritteninformationas WAC246869210(4);
requiredbyregulation. SeeWAC246869220
Includesauxiliarylabels.
ASideEffectsStatement: ***
Contactyourdoctorfor 21CFRParts
medicaladviceaboutside 201,208,
effects.Youmayreportside 209
effectstoFDAat1800FDA
1088.
Maybeomittedifprescriberrequests.
**Maybeomittediftrackedinthepatientrecordsystem.
***Maybeomittedifpresentoncontainercap,aMedicationGuide,PIL,orotherprintedmatter
presentedtopatientwitheachprescription.
135
WILLIAME.FASSETT
LABELINGREQUIREMENTSFORNONAMBULATORYPRESCRIPTIONMEDICATIONS
Drugssuppliedtohospitals,nursinghomes,andphysicianofficesmustmeetthegenerallabelingrequirements
oftheFDCA.Howthosedrugsarelabeledinthesesettingswhentheyarebeingpreparedforadministrationto
patientsisleftprimarilytostatelawor,forMedicareandMedicaidpatients,toregulationsissuedbyCMS.The
PharmacyCommissioninWashingtonhasdevelopedspecificregulationsforseveralsettings(seealsoChapter
3),whicharesummarizedintheTable42.
TABLE42.ELEMENTSREQUIREDONNONAMBULATORYPRESCRIPTIONDRUG
LABELSINWASHINGTON
Hospital, Hospital, Nonhospital, ECF,Nonunit ECF,Unit
Parenteral Inpatient Parenteral Dose Dose
WAC 246873080(5)c 246873080(5)a 246871050 246865060(4)a 246865040(4)b
PhcyName
PhcyAddress
PhcyPhone
RxNumber
24hrPhone
PtName Oncassette
PtLocation Oncassette
Prescriber
DrugName
DrugConc.or
Strength
Dosage
LotNo. Inprofile
Directionsforuse
Infusionrate
CSASched.
Quantity
DatePreparedor
Dispensed
Exp.Date (appropriate
dating)
ExpirationTime (appropriate
dating)
Storage
instructions (appropriate)
RPhInitials
PreparerInitials InProfile
AuxiliaryLabels (appropriate) (seeWAC)
TransferCaution
Label

136
USPGUIDELINESONPRESCRIPTIONCONTAINERLABELING.TheUSPpublishedGeneralChapter
<17>,PrescriptionContainerLabeling,whichbecameofficialonMay1,2013.Thegoalofthestandardsisto
reducevariabilityinthewaythatprescriptionlabelsareorganized,andtoencourageapatientcentered
approachtoprescriptioncontainerlabeling.TheNationalAssociationofBoardsofPharmacyhasrecommended
makingchangestotheModelStatePharmacyActtoincorporatetheseguidelines,butasofFebruary2015,
WashingtonlaworregulationshavenotadoptedtheUSPguidelines.Elementsoftheguidelinesinclude:
Emphasizinginstructionsandotherinformationimportanttopatients
Improvingreadability
Givingexplicitinstructions
Includingapurposeforuse
AddressinglimitedEnglishproficiency
Addressingvisualimpairment
PRESCRIPTIONDRUGCONTAINERLABELINGFORPERSONSWHOAREBLIND,VISUALLY
IMPAIRED,ORELDERLY.In2012CongressdirectedtheFDA(in904(a)(1)ofFDASIA)toconvenea
workinggrouptodevelopbestpracticesonaccesstoinformationonprescriptioncontainerlabelsforindividuals
whoareblindorvisuallyimpaired.Thegroupshallconsidertheuseofbraille,auditorymeans(e.g.,talking
bottles),andenhancedvisualmeanssuchashighcontrastprinting.
TherecommendationsresultingfromtheworkinggroupwerepublishedbytheUnitedStatesAccessBoardin
July2013(https://www.accessboard.gov/guidelinesandstandards/healthcare/aboutprescriptiondrug
containerlabels/workinggrouprecommendations).Therecommendationsweredevelopedinpartfromthe
guidelinesinUSP<17>.
Severaloptionsareavailablefordeliveryofprescriptionlabelinformationtovisuallyimpairedpatients:
Hardcopybrailleand/orlargeprint
Electronicmethodsarenowavailableincluding
o Digitalvoiceortexttospeechrecordermaybeaffixedtothecontainer
o Radiofrequencyidentificationdevice(RFID)isaffixedtocontainer,andcontainerisplacedona
readerdevice(e.g.,ScripTalkwww.envisionamerica.com)
o PatientownedsmartdevicesthatrespondtoRFIDtagorQRcode
Provisionoftheselabelingservicesisbecomingastandardofpractice,particularlyamongnationalpharmacy
chainsandmailorderpharmacies.Nationalchainsorprovidersthathaveimplementedtheserecommendations
includeCaremark,CVS,ExpressScripts,HEB,Humana,KaiserPermanente,RiteAid,Walgreens,andWalmart,
accordingtoaMarch2016updatebythelawfirmofLaineyFeingold,availableat
http://www.lflegal.com/2016/03/talkinglabel2016update/.236Inmanycases,theavailabilityofenhanced
labelingistheresultofstructurednegotiationbetweentheproviderandtheAmericanCounciloftheBlindand
oneormoreACBstateaffiliates.237
PatientsmaylocatepharmaciesusingtheEnVisionAmericaScripTalkprogramontheScripAbilitywebpage;the
sitealsoallowsthemtoindicateiftheypreferlargeprintorbraillelabels.
(http://www.envisionamerica.com/products/scripability/)
PROFESSIONALLABELINGANDPRESCRIBINGINFORMATION.Labelingofaprescriptiondrug
includesprescribinginformation,whichisoftencalledthepackageinsert.Thelawdoesnotprohibitthepatient
fromreceivingthepackageinsert.
137
WILLIAME.FASSETT
STRUCTUREDPRODUCTLABELING.In2006theFDAissuedrevisedregulationstostandardizethepackageinsert
andmakeitmoreuseablebyprescribersandpharmacists.Atutorialontherequiredproductlabelingisavailable
atCDERLearn.238Theruleisapplicableto:allnewlegenddrugsapprovedonoraftertheeffectivedate;drugs
approvedwithin5yearspriortotheeffectivedate;andolderdrugswhenthereisamajorchangeinthe
prescribinginformation.
HIGHLIGHTSOFPRESCRIBINGINFORMATIONmustbethefirstsectionoftheinsert.Itmustsummarizethe
following:
RecentMajorChanges
TheDrugApprovalDate
AdverseEventReports
TableofContents
THEMAJORSECTIONSarenownumbered,andreferredtointheHighlightsandTableofContents.Thenew
regulationsputinformationonuse,dosage,andprecautionarystatementsfirst,whereasthedescriptive
informationwasfirstinolderinserts.
1. Indicationsandusage
2. Dosageandadministration
3. Dosageformsandstrength
4. Contraindications
5. Warningsandprecautions
6. Adversereactions
7. Druginteractions
8. Useinspecificpopulations
9. Druguseanddependence
10. Overdosage
11. Description
12. Clinicalpharmacology
13. Nonclinicaltoxicology
14. Clinicalstudies
15. References
16. Howsupplied,storage,andhandling
17. Patientcounselinginformation
CONTRAINDICATIONCLARIFIED.Inaguidancedocument,theFDAmakesitclearthatacontraindicationisa
reasonnottousethedrug:Adrugshouldbecontraindicatedonlyinthoseclinicalsituationsforwhichtherisk
fromuseclearlyoutweighsanypossibletherapeuticbenefit.Onlyknownhazards,andnottheoretical
possibilities,mustbelisted.Iftherearenoknowncontraindicationsforadrug,thissectionmuststateNone
[emphasisadded].239Thephrase,relativecontraindicationhasnousefulmeaninginevidencebased
medicationuse.Arelativecontraindicationismoreproperlycalledaprecaution.
USEINPREGNANCYANDLACTATION.
InDecember2014,theFDApublishedafinalrule240thatchangeshowinformationwillbepresentedonuseof
prescriptiondrugsduringpregnancyandlactation.Priortothisfinalrule,labelingregardingpregnancyand
lactationwascontainedin3subpartsofsection8(UseinSpecificPopulations)oftheprofessionallabeling:8.1
Pregnancy,8.2LaborandDelivery,and8.3NursingMothers.Newlabelingwillconsistof3relabeledsections:
138
8.1Pregnancy(includinglaboranddelivery),8.2Lactation(includesnursingmothers),and8.3Femalesand
MalesofReproductivePotential.
Amoresubstantialchangeunderthenewguidelineswillbetheeliminationofalphabeticallettercategories
relatedtouseinpregnancy(A,B,C,D,andX).Instead,eachsubsectionwillberequiredtoprovidemore
detailedinformationfromtrialsandcurrentliterature,and,ifavailable,datafromanyexistingpregnancy
exposureregistryconcerningthedrug.
TherulebecameeffectiveonJune30,2015.NDAssubmittedonoraftertheeffectivedatemustprovidelabeling
consistentwiththerevisedrule.Manufacturersofotherproductswillhave3or4years(dependinguponthe
approvaldatefortheirNDA)aftertheeffectivedatetorevisetheirlabeling.
DAILYMEDTheFDAhasinstitutedaserviceincooperationwiththeNationalLibraryofMedicineto
electronicallydisseminateuptodateandcomprehensiveinformationforusewithinformationsystemsthat
supportpatientcare.Thissite(http://dailymed.nlm.nih.gov)isasourceofthemostcurrentlabelingforthe
drugsthatarelisted.AsofJanuary2017,over93thousandproductlabelswereavailable.
PATIENTPACKAGEINSERTS,PILS,ANDMEDICATIONGUIDES.
Manyproductsalsocontainadditionalpatientpackageinserts(PPIs),whichareintendedtobeincludedwiththe
dispensedprescription.FailuretodispenseapatientpackageinsertorMedicationGuide,unlessspecifically
directedtowithholditbytheprescriber,isconsideredmisbranding.However,ifapatientrequestsaPPIor
MedicationGuide,itmustbeprovided,eveniftheprescriberhasdirectedotherwise(21CFR208.26(b))
PPISREQUIREDBYREGULATION.TwospecificpartsoftheCFRdealwithpatientpackageinsertsfororal
contraceptivesandwithestrogens.
ORALCONTRACEPTIVEINSERTSconsistofacompleteinsertandabriefinsert.Bothmustbedispensedto
ambulatorypatientseachtimethedrugisdispensed.Inhospitals,thesemustbeprovidedtothepatientatthe
firstdispensing,andonceevery30days.
ESTROGENSalsorequireasinglepatientinformationleafletbedispensedwitheachprescriptionandeachrefill.
Inhospitals,thesemustbeprovidedtothepatientwithfirstuseofthedrug,andevery30days.
PATIENTINFORMATIONLEAFLETS(PILS).PILsaresupplementaryinformationsheetsprovidedbypharmacies
aspartoftheprescriptionprocess.Thesearegenerallywrittenby3rdpartyproviders,ofwhichFirstDataBank
andMediSpanareamongthelargest.Washingtonrequiresthatwritteninformationaccompanyprescriptions
thataredeliveredoutsidetheconfinesofthepharmacy,anditisanationalstandardofpracticetoprovide
writtenmaterialtopatientsthatexpandsandreinforcestheinformationtheyneedtoproperlyusetheirdrugs,
whichshouldalsobecommunicatedduringpatientcounseling.Thesesamevendorsprovidetheunderlyingdata
fordruginteractionscreeningandalerts.Pharmacieshaveoptionsforuseofthisdataintheirsoftware,andare
ultimatelyresponsibleforitsproperuseandreview(seeChapter6).
MEDICATIONGUIDES.TheFDAhasauthorityunder21CFR208torequireaMedicationGuideinaspecific
formattoaccompanyaparticulardrugproduct.TheFDAhasbecomeactiveinrequiringMedicationGuides,
whichreplacePILswhentheyarerequired.Eachdispenserwhichmaybeapractitionerdispensingtheproduct
toapatientmustprovidearequiredguidetothepatienteachtimethedrugisdispensed(i.e.,fornewand
refillprescriptions).241TheFDAreliesheavilyonMedicationGuidesaskeyelementsofnewlydevelopedREMS
plans(seeabove).TheFDAhasindicateditwillexerciseenforcementdiscretionconcerningtherequirement
139
WILLIAME.FASSETT
thatamedicationguidemustalwaysbeprovided,dependingonthesetting,and5specificsituations;the
followingtablesummarizestheFDAsrequirements:242
TABLE43.FDAREQUIREMENTSFORDISTRIBUTIONOFMEDICATIONGUIDES
Setting Patientor Eachtime Providedat When Drugissubject
Agent medication timeoffirst Medication toaREMSthat
Requests dispensed dispensing Guide requiresguide
materially
changed
Inpatient Must Neednot Neednot Neednot Mustprovideas

provide provide provide provide specifiedin
REMS
Outpatientwhen Must Neednot Mustprovide Mustprovide Mustprovideas

dispensedto provide provide specifiedin
professionalfor REMS
administrationto
patient(e.g.,clinic,
infusioncenter,ED)
Outpatientwhen Must Must Mustprovide Mustprovide Mustprovideas

dispenseddirectlyto provide provide specifiedin
patientorcaregiver REMS
(e.g.,retailpharmacy,
hospitaloutpatient
pharmacy,patient
samples)
DRUGSREQUIRINGMEDICATIONGUIDES.AlistofdrugsrequiringMedicationGuidesispostedontheFDA
website(http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm),andthesitehasalinkallowinginterested
personstosignupforemailnotificationswhenthelistchanges.ParticularclassesofdrugsforwhichMedication
Guideshavebeendevelopedthatarefrequentlyoverlookedbypharmacists,resultinginpotentiallegalliability,
include
Anticoagulants
Anticonvulsants
Antidepressants
Antidiabeticagents
NSAIDSpayparticularattentiontowarningsaboutrashes,SJS,andTEN
Opiates
BenzodiazepinesandZdrugs,(e.g.,zolpidem,zaleplon)
FDAINDEXTODRUGSPECIFICINFORMATION.TheFDAprovidesanindextocurrentlymarketeddrugsfor
whichspecificFDAinformationmaterialshavebeenpublished.TheseincludeHealthCareProfessional,Patient,
orConsumerInformationSheets,MedicationGuides,orInformationPages.Theindexcanbeaccessedat
140
http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111085.
htm.
EXPIRATIONDATES
Manufacturersmustplaceanexpirationdateonthecontainersoflegenddrugs,aswellasalotnumber.As
pharmacistsknowfromtheireducationinpharmaceutics,thesedatesgenerallyreflectatimewhenatleast95%
ofthedrugslabeledpotencyisstillavailable,andnoundesirabledegradationhastakenplace.Thesedatesare
usuallyassignedveryconservativelybymanufacturers.Iftheexpirationdateisspecifiedintheformofamonth,
day,andyear,thedrugmaynotbedispensedafterthatdate.Ifthedateisspecifiedasamonthandyearonly,
thenthedrugisconsideredexpiredafterthelastdayofthemonthindicated.Pharmacistsshouldnotdispensea
quantityofdrugthatcannotbeusedbythepatientpriortotheexpirationdate.
USEBEFOREORDISCARDAFTERDATES.Washingtonregulations(WAC246869210(1))specifythatin
determiningaUseBefore(orDiscardAfter)datetoplaceonadispensedprescription,thepharmacistmust
considerseveralfactors,including
THENATUREOFTHEDRUG;
THECONTAINERINWHICHITWASPACKAGEDBYTHEMANUFACTURERANDTHEEXPIRATIONDATE
THEREON;
THECHARACTERISTICSOFTHEPATIENTSCONTAINER,ifthedrugisrepackagedfordispensing;
THEEXPECTEDCONDITIONSTOWHICHTHEARTICLEMAYBEEXPOSED;
THEEXPECTEDLENGTHOFTIMEOFTHECOURSEOFTHERAPY;and
OTHERRELEVANTFACTORS.
Itispermissibletodispensemedicationsinthemanufacturersoriginalcontainer,andtheexpirationdateand
lotnumbermaybeleftvisibletothepatient.ManystatesimposeaoneyearlimitontheUseBeforedate,but
thereisnosuchlimitinWashington.MANYCOMPUTERSYSTEMSUSEDBYRETAILPHARMACIESDEFAULTTOA
ONEYEARUSEBEFOREDATE.CareshouldbetakentoOVERRIDETHISDEFAULTIFTHEACTUAL
MANUFACTURERSDATEISEARLIERthanoneyearfromthedatedispensed.
REGULARINSPECTIONOFDRUGSTOCKSREQUIRED.PharmacistsarerequiredbyregulationinWAtoregularly
inspectdrugsinthepharmacyandremoveproductsfromtheirstockwhenthemerchandisehasexceededits
expirationdate.(WAC246869150(2))Outdateddrugsareconsideredadulterated.
PRESCRIBERSWHODISPENSEDRUGSmustlabeltheprescriptionsinaccordancewiththesame
standardsthatarerequiredforpharmacists.(RCW69.41.050)
THELABELmustcontainthenameofthepatient,name,strengthofthedrug,thedate,thenameofthe
prescriber,andcompletedirectionsforuse.Thedrugnameanddirectionsmaybeomittedonthebasisofa
consideredjudgmentbytheprescriber.
SAMPLEPACKAGESneedtocontainthenameoftheprescriberandthenameofthepatient.Thisisveryseldom
actuallydone,however.Itisparticularlyforprescribershandingoutsamplesofcontrolledsubstancestofollow
thisrule;theirpatientsmaybechargedwithunlawfulpossessionofthedrugsiftheirnamesarenotonthe
package.
NURSESORMEDICALASSISTANTSMAYNOTDISPENSELEGENDDRUGS,soifaprescriberdispensesadrugheor
shemustdoitpersonally.Prescribersmaynotdispensedrugsforotherprescribers.(ExceptthatPAsmay
dispensedrugsorderedbytheirsupervisingphysician.)
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WILLIAME.FASSETT
TheNursingCommissionin2016issuedanadvisoryopinioninwhichitdeclaredthataregisterednurse(RN)
maydistribute,deliver,ordispenseprescriptivemedications/devicesforreproductivecareandpreventionand
treatmentofcommunicablediseasesaccordingtoawrittenorstandingorderofanauthorizedprescriber.The
advisoryopinionappliestoRNsemployedbypublichealthprograms,subjecttospecificguidelinesexpressed
intheadvisoryopinion.243Labelsarerequiredtocontainthesameelements,includingdirectionsforuse,asare
requiredonoutpatientpharmacylabels.
VETERINARIANSarerequiredbytheirdisciplinaryboardtoincludecompletedirectionsforuse,thenameofthe
clientoridentificationoftheanimal,thenameofthedrugandstrength,andnameofprescribingveterinarian.
Noexceptionismadeforsamplesinthisrule.(WAC246933340(5)(b))
PrescribersareequallysubjecttotheUSPREQUIREMENTSforstorageandDISPENSINGCONTAINERS,forto
storeordispensedrugsinviolationofcompendialstandardsistosubjectthedrugstoadulterationunderthe
FDCA.
PrescribersmustalsoadheretothePOISONPREVENTIONPACKAGINGRULES,exceptthattheymayspecifynon
CRCcontainersonacasebycasebasisforindividualpatients.
ELEMENTSOFAPRESCRIPTION
AllofthefollowingconditionsmustbepresenttoauthorizeapharmacisttodispensealegenddruginWA.(RCW
69.41.040)
WRITTENFORASPECIFICPATIENT.Eachprescription
ELEMENTSNEEDEDFORAVALID
shouldbewrittenforaspecific,namedpatient.Inordertofulfill
PRESCRIPTION theobligationstopreventadversedrugreactionsandconduct
SPECIFICPATIENT drugusereview,thepharmacistmustbeabletomatchthe
prescriptionorderwithaparticularpatientsprofile.Some
AUTHORIZEDPRESCRIBER patientshaverequestedthattheybeallowedtouseacode
nametoshieldtheiridentity(e.g.,HIVpositivepatients),butthe
DUECOURSEOFPRACTICE BoardofPharmacyatthetimerejectedtherequest.HIPAA
MEDICALPURPOSE requirementsshouldbesufficienttoassureconfidentialityto
thosepatients.Sometimesprescriptionsarewrittenforallthe
membersofafamily,orarewrittenforonespousewhohas
insurancetoprovidedrugfortheuninsuredspouse.Thesearechallengesforthepharmacist,andthese
prescriptionsaretechnicallyinvalid.
NaloxonemaybeprescribedforcaregiversofpatientsreceivingorourusingopioidsunderWAlaw.(Seechapter
5)Inaddition,"partnertherapy"forSTDsisanexceptiontotherequirementforaspecificallynamedpatient
(seebelow).
Washingtonrulesrequirethatdrugsbedelivereddirectlytothepatient,personpickinguptheprescriptionfor
thepatient,orpersondeliveringtheprescriptiontothepatientathisresidenceorsimilarplace.(WAC246869
020(4)).DEArulesrequiredeliveryofcontrolledsubstanceprescriptionsonlytotheultimateuseroramember
ofhisorherhousehold.(SeeChapter5)
WRITTENBYAUTHORIZEDPRESCRIBERS(RCW69.41.030)
Allstatesallowphysicians,podiatrists,dentists,andveterinarianstoprescribelegendandcontrolledsubstances.
Otherpractitionersmayormaynothaveprescriptiveauthorityforoneormoreclassesofdrugs
142
Allstateshonorprescriptionsfromoutofstatephysicians,podiatrists,dentists,andveterinarians.
Washingtonallowsfullorpartialprescriptiveauthoritytoavarietyofpractitioners.Table43summarizes
prescriptiveauthorityandscopeofpracticeinWA.Thistablealsoincludesacademicandotherabbreviations
commonlyusedbyprofessionalswhopracticeinhealthcaresettings.
PRACTITIONERSoutofstateprescriptionsareacceptable.WAallowsthefollowingprescriberswhoare
licensedinanystateorUSterritory,orinBritishColumbia,toissueprescriptionsforlegenddrugsthatarevalid
inWA.(Note:Canadianprescriberscannotissueprescriptionsforcontrolledsubstancesunlesstheyarealso
licensedintheUSandregisteredwiththeDEA.)
Physicians(MD)andOsteopathicPhysicians(DO)
Dentists(DMD,DDS)
Podiatrists(PodD,DPM)
Veterinarians(DVM)
NursePractitioners(ARNP)
PhysiciansAssistants(PA,PAC)
MIDLEVELPRACTITIONERSoutofstateprescriptionsarenotallowedfromthesepractitioners.
NurseAnesthetists(CRNA)
Optometrists(OD)
Naturopaths(ND)inDecember2014,theDepartmentofHealthhassubmittedaSunriseReviewof
theNaturopathicscopeofpractice,recommendingchangesinthestatutetopermitexpanded,butstill
limited,prescribingofcontrolledsubstances.244
Midwives(verylimited)
Pharmacists(R.Ph.,Pharm.D.)undercollaborativepracticeagreements
Physicaltherapists(R.P.T.,Dr.P.T.)andOccupationalTherapists(O.T.,Dr.O.T.)maynotprescribe,but
mayorderandusecertainlegenddrugs.
EastAsianMedicinePractitioners(acupuncturists)mayprescribe,orderandusecertainsterile
injectabledrugs(e.g.,sterilesaline,waterforinjection,vitamins)aspartofpointinjectiontherapy.The
2016Legislatureamendedthestatutetodefinepointinjectiontherapy:asdefinedbyrulebythe
department.Pointinjectiontherapyincludesinjectionofsubstances,limitedtosaline,sterilewater,
herbs,minerals,vitaminsinliquidform,andhomeopathicandnutritionalsubstances,consistentwith
thepracticeofEastAsianmedicine.Pointinjectiontherapydoesnotincludeinjectionofcontrolled
substances...orsteroids...(RCW18.06.010(1)(j))245ThesamelegislationaddedEastAsianmedicine
practitionertothelistofauthorizedprescribersinRCW69.41.
PRESCRIBINGBYPHARMACISTS.ThePharmacyCommissionhaslimitedauthoritytorevieworapprove
collaborativepracticeagreementsforpharmacists.Thestatute(RCW18.64.011(11))definesthepracticeof
pharmacytoincludeinitiatingormodifyingofdrugtherapyinaccordancewithwrittenguidelinesorprotocols
previouslyestablishedandapprovedforhisorherpracticebyapractitionerauthorizedtoprescribedrugs.The
phrase,initiatingormodifyingdrugtherapyistantamounttosayingprescribing.Sincethisauthorityis
inherentinthelicensetopracticepharmacy,thestatutedoesnotauthorizerestrictionofprescriptiveauthority
topharmacistswithparticularlevelsoftrainingorexperience.Aslongastheprotocolorguidelineisinwriting,
andapprovedbyanauthorizedprescriber,thepharmacistmayproceed.
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WILLIAME.FASSETT
COLLABORATIVEDRUGTHERAPYAGREEMENT(CDTA)PROCESS
CDTASARENOTTHEONLYMEANSBYWHICH ApprovedbyPQAC,July2014
APHARMACISTMAYEXERCISEPRESCRIPTIVE 1.ACDTAispermittedtoincludeasinglepharmacistoragroupofpharmacists
exercisingprescriptiveauthorityunderthedelegationofapractitioner
AUTHORITY;thestatutecallsfor"written authorizedtoprescribe.
guidelinesorprotocols,"approvedbya a.Theauthorizingprescribershalldeterminetheappropriatenumberof
pharmacistsauthorizedtoprescribeundertheprescribersauthority.
practitionerforthepharmacist'spractice.The b.Theauthorizingprescribershalldeterminethescopeofpracticedelegatedand
useofawrittenagreementbetweenindividual shallsetanylimitationsoftheprescribingthathasbeendelegated.
pharmacistsandindividualprescribersemerged 2.ACDTAshallbefiledwiththePharmacyQualityAssuranceCommission(PQAC)
inthefollowingformats:
inotherstatesaftertheWashingtonstatute a.Adocumentlistingasingleprescriberandasinglepharmacistwithboth
wasenacted.Thus,a"CollaborativeDrug partiessignatures,or
TherapyAgreement"isoneformatfor b.Adocumentlistingasingleprescriberandmultiplepharmacistswiththe
prescriberandmultiplepharmacistssignatures.
recordingprotocolsorguidelinesapprovedfor Electronicorwetsignatureoftheprescribermustbedatedafterallpharmacist(s)
anindividualpharmacist'spractice,butitisalso havesignedanddatedtheagreement.
appropriateforstatewideprotocols,or 3.UponfilingoftheCDTAwiththePQACeachpharmacistwillbeassigneda
uniqueCDTAidentifier.
protocolsissuedbyacountyhealthmedical
4.ACDTA:
director,orbyapharmacyandtherapeutics a.Shallbecontinuallyupdatedtoreflectallcurrentpharmacist(s)coveredbythe
committeetobethebasisforapharmacist's agreement.Thisincludesbothadditionsanddeletionsofpharmacist(s).Achange
intheauthorizingprescriberwillrequireanewCDTAbefiled.*
prescriptivepractice.Inthefollowingmaterial,
b.Anewpharmacistmaybeaddedtotheagreementduringthetwoyearperiod
whenIrefertoaCDTA,Iamalsoincluding theagreementisonfilebysubmittingtothePQACadocumentsignedbythe
otherwrittenguidelinesorprotocols,unlessit authorizingprescriberandthepharmacistandacopyoftheCDTApreviously
isclearotherwisefromthecontext. filed.
c.Theadditionordeletionofapharmacist(s)doesnotextendthePQACs
assignedexpirationdate.
The2013legislaturerepairedanomissionin
5.EmployersmayfacilitatethefilingandmanagementofaCDTAonbehalfofa
RCW69.41.030byaddingpharmaciststothe pharmacist(s)andprescriberhowever;
listofpersonswhocouldprescribelegend a.ACDTAisanagreementbetweenapharmacistandaprescriber.
drugs.Theexactlanguageusedincludeda b.Itisnotanagreementbetweenacorporationoranemployerandaprescriber.
c.Employersmaynotrestrictorimposelimitationsoncommunicationbetween
pharmacistunderchapter18.64RCWtothe thepharmacist(s)andtheauthorizingprescriber.
extentpermittedbydrugtherapyguidelinesor 6.WhenaCDTAisfacilitatedbyanemployer:
protocolsestablishedunderRCW18.64.011 a.TheemployermaycoordinatetheQAprogramorsystemsthatsupportWAC
246863100(2)(d)usedtoprovidetheauthorizingprescriberwith
andauthorizedbytheboardofpharmacy246 documentationofdecisions,communicationandfeedback.
andapprovedbyapractitionerauthorizedto b.Anemployerthroughpolicymaylimittheimplementationofapharmacists
prescribedrugsTheimportofthephrase CDTAwithintheemployerssetting.
*Note:WhenmultipleprescribershavesignedtheCDTA:
authorizedbytheboardofpharmacymaybe a.AchangeinoneormoreoftheauthorizingprescribersdoesnotrequireanewCDTAas
subjecttofurtherinterpretation,butasof longasatleastoneoftheotherauthorizingprescribersiscontinuingtoauthorizethe
prescriptionauthoritydelegatedintheCDTA.
January2017,theCommissionhasnot b.AnewCDTAshallberequiredifthereisachangeinscopeofthedelegation,whetherby
interpretedthistoallowittoapproveCDTAs. amendmentfromtheauthorizingprescriberorbyremovalofanauthorizingprescriberwho
haddelegatedspecific(qualifiedorlimited)prescriptionauthorityandnootherauthorizing
prescriberontheCDTAisdelegatingthespecificprescriptionauthoritytothepharmacist(s)
TheCommissionhasdevelopedrulesthat
establishappropriateelementsbecontainedinacollaborativepracticeagreement(WAC246863100):
AwrittencopyoftheapprovedprotocolmustbeonfileinthepharmacyandonfilewiththeBoardof
Pharmacy.Theprotocolmustcontain:
Theidentityoftheauthorizingpractitionerandthepharmacist(s)authorizedmustbestated.The
guidelinemayauthorizeapharmacistoragroupofpharmacists.
Atimeperiod,nottoexceed2years,duringwhichtheprotocolwillbeineffect.
Astatementofthetypeofprescriptiveauthorityauthorized,thatincludes:
144
Typesofdiseases,drugs,ordrugcategoriesincluded,andthetypeofauthority(i.e.,initiatingor
modifying)allowedforeachtype.
Ageneralstatementoftheprocedures,decisioncriteriaorplanthepharmacistwillfollowwhenmaking
therapydecisions.
Astatementoftheactivitiesthepharmacististofollowwhenexercisingprescriptiveauthority,including
documentationofdecisionsmade,andaplanforcommunicationorfeedbacktotheauthorizing
prescriberconcerningdecisionsmade.Theregulationallowsdocumentationontheprescription,ina
patientchart,patientmedicationprofile,orseparatelogbook.TheCommissionhasstruggledwiththe
processforreceivingandrecordingcollaborativepracticeagreements,particularlyasthenumberof
authorizedpharmacistsgrewexponentiallyduetoimmunizationprotocols.InJuly,2014,the
Commissionadoptedapolicytoclarifytheprocess(seesidebar).Nochangewasmadetotheexisting
rule.
AtitsSeptember30,2016meeting,theCommissionrecognizedthataCDTAisanagreementbetweena
pharmacistandthedelegatingprovider,andremoveditsinternalprocessrequirementthattheCommission
staffreviewtheCDTAandsendaletterofacknowledgementtothepharmacistwhenaCDTAisfiledwiththe
Commission.ItadoptedtheproposedrevisedpracticeforhandlingCDTAs:(1)apharmacistprocuresaCDTA
withapractitioner;(2)ThepharmacistoremployerfillsoutaCDTAreviewformthataidscredentialingin
providingtracking(anumberingsystem);(3)thepaperworkisrecordedwithcredentialingforthelicensee;(4)...
acopyisthenonfilewithDOHandacopyisonfileatthepharmacistsplaceofpractice.247
DUTIESOFAPHARMACISTINAPRESCRIBINGROLE
Thepharmacistwhoundertakestoprescribeormodifytherapyunderprotocolassumesallthedutiesofany
otherprescriber,andisnolongerjustdispensingmedicationsbasedontheprescribingdecisionsofothers.The
prescribingprocessinvolvesatleastthefollowingelements:
ADHERINGTOAPATIENTCAREPROCESS.AllmajorUSpharmacyorganizationshavejoinedtogetherto
adoptandendorseastandardizedPharmacistsPatientCareProcess.AsnotedbytheJCPP,the
PharmacistsPatientCareProcessusesapatient
centeredapproachthatdependsfirstandforemost
onthepharmacisthavinganestablishedrelationship
withthepatient.Thisrelationshipsupports
engagementandeffectivecommunicationwiththe
patient,family,andcaregiversthroughoutthe
process.Theprocessalsoinvolvesthepharmacist
workingwithprescribersandotherpractitionersto
optimizepatienthealthandmedication
outcomes.248Whilethisprocessappliesinall
settingsandtoallpharmacistsroles,itisparticularly
relevanttocollaborativedrugtherapymanagement.
Attheheartoftheprocessistheuseofevidence
basedpractice.Theplanforanynewormodified
therapymustresultasaresultofcollectionof
relevantpatientinformationandassessmentofdrug
therapyrelatedproblems.
IDENTIFYINGANINDICATIONORDIAGNOSIS.Inacollaborativesetting,thepharmacistmayberelyingon
anotherprovidertomakethediagnosis,andcollaborativedrugtherapymanagementisoftencalled
postdiagnosisprimarycare.However,thepharmacistmustbeclearonthenatureofthediagnosisor
145
WILLIAME.FASSETT
indicationthatnecessitatesthetherapyheorsheisprescribingormodifying.Theindicationfortherapy
mustbedocumentedinthepatientrecord.
OBTAININGINFORMEDCONSENTTOTHERAPY.Thepatienthasarighttorefuseanyproposedtreatment,
andhisorheragreementtoatreatmentmustbebasedonbeingprovidedwithinformationnecessary
tomakethatconsentaninformedone.Theelementsofpatientcounselingthatapplytothe
pharmacistsdispensingrolearenotsufficienttoobtaininformedconsent.Thissubjectiscoveredin
moredetailinChapter7.Allprescribingbyapharmacistshouldbebasedonthepharmacists
documentationthatthepatienthasanunderstandingoftherisksandbenefitsoftherapyandhas
agreedtothetreatment.Ifanotherpractitionerhasclearlydocumentedthatconsentwhichis
commoninclinicsettingsthepharmacistmaybeabletorelyonthatdocumentation.
PROPERDOCUMENTATION.Documentationofdispensingdecisionsisgenerallyquitelimited,with
pharmacistsmakingspecificnotesonlyinnonroutinetransactions,suchaswhenaDURalerthasbeen
respondedto.Theexpectationforprescribersisthatthepatientencounterisfullydocumented,using
SOAPnotesorotherstandardizedformats,andmakingitclearinthepatientrecordwhoformulatedthe
planandtheprescriptionorordermodifyingtherapy.Communicatingthedecisiontootherhealthcare
providersinvolvedinthepatientscareisacriticalaspectoftheprescribingprocess.Insettingswhere
pharmacistsarebillingforservicestothirdpartypayers,thedocumentationmustincludeallthe
informationnecessarytoprovidetheproperdiagnosticandprocedurecodesontheclaim.Miscoding
canresultinsignificantpenalties(seeChapter8).
FOLLOWUP.Theprescriberisresponsibleformonitoringtheresultsofhisorherprescribingdecisions,
andthepharmacistengagedincollaborativepracticebearstheresponsibilityoffollowingupwiththe
patientorwithotherswhowillimplementtheprescribedtreatment.Inarecentcase,apharmacist
issuedanordertomodifythemorphinedosingrateforapatientcontrolledanalgesia(PCA)pump.The
pharmacistneverreturnedtofollowuponthechangeand,duetoanursingerror,thepatientwas
overdosed.Neitherthepharmacistdoingthedosingnorthepharmacistwhosuppliedanearlycartridge
changecaughttheerror,andthepatientdied.
ISSUINGTHEPRESCRIPTIONORORDERBYAPHARMACIST
Thepharmacistwhoinitiatesormodifiestherapymustgenerateaprescriptionororder,justaswouldanyother
prescriber.Aphysicianwhodispensesmedicationtohisorherpatientsmustrecordtheorderinthepatients
chartaswellasmaintainingadispensingrecord.InWashington,thepharmacistmustsigntheprescriptionor
orderjustasanyotherprescriberwoulddo.Itisnotappropriatetoissueaprescriptionunderthenameofthe
prescriberapprovingtheCDTA,protocol,orguideline.Thus,thepharmacistissuinganorderthatwillbe
administeredordispensedbyanotherprovidermustindicatehisorherNPIontheprescription,and,ifitisfora
controlledsubstance,hisorherDEAnumber.Apharmacistchangingaprescriptionorissuingarefilltoapatient
basedonaprotocolshouldrecordhisorhernameastheauthorizingprescriber,nottheprescriberwhoissued
theoriginalprescription.Aswithotherprescribers,prescriptionswrittenbypharmacistsandgiventopatients
mustbeonprescriptionblanksthatconformtostatetamperresistantrules.
PITFALLSINCOLLABORATIVEPRACTICEANDPHARMACISTPRESCRIBING
Thefollowingaresomeexamplesthathaveledtodifficultiesforpharmacistsengagedincollaborativepractice.
NOTHAVINGTRULYREADTHECDTA.Pharmacistsmaycomeintoapracticewherecertainprotocolsare
inplace,andlearnbydoingtheprotocols,withouthavingactuallycompletelyreadtheprotocolor
evenknowingforsurethattheyarenamedintheprotocol.
FAILINGTOADHERETOTHECDTA.Insomeimmunizationsettings,pharmacistshavefailedtofollow
protocolguidelinesonsanitation,privacy,orknowingwheretheemergencykitistobefound.In
146
anothercase,thepharmacistsinvolvedinmonitoringaminoglycosidetherapyfailedtofollowthe
monitoringguidelinesforthetypeoftherapyordered,andfailedtorequiredocumentationofthe
indicationfortreatmentasspecifiedintheprotocol.
NOTEXPLAININGTOTHEPATIENTthatthepharmacistisoperatingunderaprotocolorguideline.This
mayleadtounnecessarymisunderstandings,andalsomissesanopportunitytoeducatethepatienton
thebroaderrangeofservicesnowavailablefrompharmacists.
RELYINGONALOOSELYWRITTENORAMBIGUOUSCDTA.Arecentcaseinvolvedapharmacistwhose
CDTAverybroadlydescribedthedrugshecouldprescribe.Whenapatientwasinjuredbypoor
prescribingdecisionsofthephysician(notthepharmacist),thepharmacistwasalsosuedonthegrounds
thattheCDTAallowedhimtoprescribethedrugsinquestioneventhoughneitherhenorthe
prescriberintendedthosedrugstobecovered.Itisnotagoodideaforapharmacisttohaveauthority
beyondwhatheorsheistrainedorpreparedtodeliver.
FAILURETODOCUMENTORCOMMUNICATE.Inacasewherethepharmacistworkedinaclinic,the
pharmacistsprescribingdecisionswereenteredintothepatientchart,butonecouldnottellwhether
thephysicianorpharmacisthaddoneso.Thepharmacistneverreviewedorsignedtheentries,onlythe
physiciandidso.Thisledtochallengeswhenthephysicianspoorprescribingwasblamedonthe
pharmacist.Pharmacistsinanothercasemanagedapatientstreatmentwithgentamicinforover21
dayswithouteverassuringthattherisksofvestibulartoxicityfromprolongedtreatmenthadbeen
documentedashavingbeendiscussedwiththepatient.
EXTENDINGPROTOCOLAUTHORITYtootherpharmacistsorstudentpharmacists.Inonecase,a
pharmacistallowedhisresidenttocallthepharmacyandissuetheprescription,usingtheresidents
nameastheprescriber,buttheresidentwasnotnamedintheprotocol(and,coincidentally,the
protocolhadexpired).Inanothercase,studentpharmacistsonAPPErotationsatthesitewereallowed
tocalculateandwritedosinginstructionsforpaintherapyandaminoglycosidetherapy,signingtheir
ownnamesinthechart.Whilethiswasokayforthestudentstodounderthesupervisionofthe
preceptor,theorderswereinvalidwithoutthepharmacistsreviewandsignature.
USINGACDTATOORDERMEDICALDEVICES.Thestatuteauthorizingpharmaciststoinitiateormodify
therapyonlyappliestodrugs,notdevices,sotheorderofanauthorizedprescriberotherthana
pharmacistisrequiredtoauthorizethedispensingofprescriptiononlydevices.Thisisnottosaythata
pharmacistmaynotinstruct,demonstrate,oradministeradevice,buttheycannotbeauthorizedto
prescribeit.(Notethatadrugdeliverysystem,suchasaprefilledsyringe,istreatedasadrug,nota
device.)
MANAGINGPOORLYDESIGNEDTHERAPY.Whendrugsareprescribedbyanotherpractitionerwith
pharmaciststodose,underprotocol,orsimilarmeansofhavingthepharmacistmanagethedosing
andadministrationofadrug,thepharmacistcarryingoutthemanagementisdoingmorethanjust
dispensing.Authoritytoprescribeadifferentdosetrulyencompassestheneedtodecideifanydoseis
appropriateforthepatient,andtodeclinetodoseapoorlyprescribeddrug.Anotherwayofexpressing
thisissueisthatwhenapharmacisttakesoverthedosingofadrugheorshetakesownershipofthe
underlyingdecisiontousethedruginthefirstplace.
FAILINGTOANTICIPATEPROBLEMS.Inothercoursesinpharmacyprograms,studentpharmacistsare
trainedinpatientsafetyandintheuseoftoolssuchasFMEA.WhentheCDTAisdeveloped,a
reasonableforwardlookingassessmentofhowthingscouldgowrongshouldbeundertaken.
147
WILLIAME.FASSETT
TABLE44.PRACTITIONERANDPROFESSIONALDESIGNATIONS
ANDPRESCRIBINGLIMITSINWASHINGTON.
(REVISEDJANUARY26,201720022017,WILLIAME.FASSETT)
Thistableprovidesdescriptionsofcommonacademicdegreesand/orprofessionaldesignationscommonlyencounteredinthehealthcare
environment.Italsodiscussesdrugrelateddispensing,use,orprescribingauthorityissuedtocredentialedhealthcareprovidersin
Washington.
Designation* Indicates LawRef.** PrescribingLimits
A.R.N.P.(alsoCNP AdvancedRegistered RCW18.79.250; Drugsnecessaryfortreatmentofpatientswithinspecialty;C5
clinicalnurse NursePractitioner WAC246840410 controlledsubstances.MayprescribeC2,3,and4ifwithinscope
practitioner;FNP etseq.;RCW ofspecialty.IfhasC2to4authority,maydispenseuptoa72hr.
familynurse 69.50.100(w)(3) supply,inadditiontoprescribing.Mustplaceinitials,ARNPonRx.
practitioner,etc.) Examplespecialtyareas:familypractice(childrenandadults);
psychiatric;pediatric;womenshealth;nursemidwife.Prescriptions
forlegenddrugsandcontrolledsubstancesmaybefilledwhen
issuedbyoutofstateARNPs.
C.Ph.T. CertifiedPharmacy RCW18.64A;WAC Apharmacytechnicianwhohaspassedacertifyingexamination
Technician 246869060 providedbythePharmacyTechniciansCertificationBoard(the
PTCE)ortheInstituteforCertificationofPharmacyTechnicians(the
ExCPT).Aswithotherpharmacytechnicians,mayassistpharmacists
byperformingnondiscretionarytasksrelatedtodispensing.No
authoritytoprescribeoradministerdrugs.
C.P.M. CertifiedProfessional Seemidwives
Midwife
C.R.N.A. CertifiedRegistered RCW18.79.240(r) Drugsusedinanesthesiapractice;scopeofpracticeestablishedby
NurseAnesthetist AmericanAssociationofNurseAnesthetists.Mayprescribedrugs,
includingC2toC5foranesthesiainaccordancewithprotocols
approvedwithinthefacility.Thisisaspecialtyareapracticedby
ARNPsinWashington.
D.C. DoctorofChiropractic RCW18.25 Noprescriptiveauthority
D.D.S.,D.M.D. DoctorofDentalSurgery, RCW 18.32 SamescopeasMDaslongastreatingdiseasesoftheheadand
DoctorofDental neck.
Medicine
D.N.P. DoctorofNursing Aclinicaldoctorateawardedtonurses;itisintendedtobecomethe
Practice;seeR.N. primarycredentialfornursecliniciansandnursepractitioners.
SamescopeasA.R.N.P.
D.O. DoctorofOsteopathy; RCW18.57 OsteopathicPhysicianandSurgeon;samescopeasMD
D.P.M DoctorofPodiatric RCW18.22 Podiatryisthediagnosis andtreatmentofdiseasesofthefoot.
Medicine,seealso Podiatristsmaynotamputatefeet,administerspinalorgeneral
Pod.D. anesthesia,ortreatsystemicconditions.Mayprescribealldrugs
andcontrolledsubstancesnecessaryinthepracticeofpodiatry.
PrescriptionsmaybefilledfromoutofstatepodiatristsinWA.
Dr.O.T.,O.T. DoctorofOccupational RCW18.59.160 maypurchase,store,andadministertopicalandtransdermal
Therapy,Occupational medicationssuchashydrocortisone,dexamethasone,fluocinonide,
Therapist topicalanesthetics,lidocaine,magnesiumsulfate,andothersimilar
medicationsforthepracticeofoccupationaltherapyasprescribed
byahealthcareproviderwithprescribingauthority
Administrationofmedicationmustbedocumentedinthepatient's
medicalrecord.Somemedicationsmaybeappliedbytheuseof
iontophoresisandphonophoresis.Anoccupationaltherapistmay
notpurchase,store,oradministercontrolledsubstances.A
pharmacistwhodispensessuchdrugstoalicensedphysical
therapistisnotliableforanyadversereactionscausedbyany
methodofusebytheoccupationaltherapist.

148

Dr.P.T.,R.P.T. DoctorofPhysical RCW18.74.160 Maypurchase,store,andadministermedicationssuchashydrocortisone,
Therapy,Registered fluocinonide,topicalanesthetics,silversulfadiazine,lidocaine,magnesium
PhysicalTherapist sulfate,zincoxide,andothersimilarmedications,andmayadministersuch
otherdrugsormedicationsasprescribedbyanauthorizedhealthcare
practitionerforthepracticeofphysicaltherapy.Apharmacistwhodispenses
suchdrugstoalicensedphysicaltherapistisnotliableforanyadverse
reactionscausedbyanymethodofusebythephysicaltherapist.
D.V.M. DoctorofVeterinary RCW18.92;WAC Unlimitedscopeaslongastreatinganimals.Mayprescribeforanimalsand
Medicine 246933340(5)b prescriptionsmaybefilledbypharmacists.Maydispensedrugsforprescribed
byotherveterinarians,subjecttocertainlimits.Veterinariansarenotableto
obtainanNPI,sothepharmacymustbeabletorecordsomeotheridentifier
whendispensingveterinaryprescriptions.
E.A.M.P.;M.Ac., EastAsianMedicine RCW18.06;WAC RevisednameforacupuncturistinWashington.Mayperformacupunctureand
M.Ac.O.M. Practitioner;Mastersin 246803 othertherapiesincludingpointinjectiontherapy.Mayprescribecertain
Acupuncture;Masters injectableproductsaspartofpointinjectiontherapy.Mayrecommendorsell
inAcupunctureand herbs,vitamins,minerals,dietaryormineralsupplements.Mayusesuperficial
OrientalMedicine heatandcoldtherapies.
J.D. JurisDoctor(doctorof Attorney.Noprescriptiveauthority.Byconvention,withinlegalcircles
law) attorneyswhoholdtheJ.D.donotusethetitledoctor,butarereferredtoas
Mr.,Ms.,etc.
L.Ac. Licensedacupuncturist RCW18.06 SeeEastAsianMedicinePractitioner
L.P.N. LicensedPracticalNurse RCW18.79 Mayadministerprescribeddrugs.
M.D. DoctorofMedicine, RCW18.71 Alldrugsneededforhisorherpatients.Nolimitsoncontrolledsubstances
PhysicianandSurgeon unlessrestrictedforagivenpractitionerbytheboardofmedicalexaminers.
Midwife,CPM LicensedMidwife(nota WAC246834 Permittedto orderandusedrugsneededindeliveryandimmediatelypost
nursemidwife); 250 partum.Mayprescribealimitedlistofproducts,andpharmacistsmayfilltheir
CertifiedProfessional ordersfordiaphragmsissuedforpostpartumwomen.
Midwife
NurseMidwife ARNP AspecialtyareaofpracticeforARNPs,sameauthorityasARNPs.
N.D. DoctorofNaturopathy RCW18.36A; AlllegenddrugswiththeexceptionofBotulinumtoxin(e.g.,Botox)andinert
WAC246836 substancesusedforcosmeticpurposes.Nondrugcontraceptivedevices.
210 Controlledsubstancesarelimitedtocodeineandtestosteroneproductsthat
arecontainedinSchedulesIII,IV,andVinchapter69.50RCW.Maynottreat
malignanciesexceptincollaborationwithaphysician(MDorDO).Seenotein
textconcerningthe2014SunriseReview.
O.D. DoctorofOptometry RCW18.53;WAC Prescribeseyeglassesandcontactlenses,andtreatsminoreyeconditions.
246851580, Mayorderandusetopicalophthalmicproductsfordiagnosisandrefraction
590 andmayprescribetopicalophthalmicandprescribecertainoraldrugsincluding
C3,4,and5drugs,andmayalsoorderandadministerepinephrineinjection
foranaphylacticshock.Mayprescribehydrocodoneproductsonlyinschedule
2.AlloweddrugsarelistedinWAC246851580and590.Limits:
Benzodiazepinesforantianxietyassociatedwithproceduressingledosesper
Rx;CSAnotmorethan7days;C3orC4,notmorethan30dosageunits/Rx.
NotationofpurposerequiredonRx.
PA PhysiciansAssistant RCW18.57A; PA:Mayprescribelegenddrugsandcontrolledsubstancesifspecifically
PAC PhysicianAssistant 18.71A;WAC designatedbylicensingauthority.OsteopathicPAmaynotprescribeC2s.
Certified 246854030; PAC:Mayprescribelegenddrugsandcontrolledsubstances.
OsteopathicPhysicians WAC246918 BothPAandPAC:Limitedtoalistofdrugsapprovedbysupervisingphysician.
Assistant 030,035. Mustwriteonsupervisingphysiciansprescriptionblank.NeedsownDEA
OsteopathicPA numberifprescribingCSAs.Maydispensedrugsfromofficewhenprescribed
Certified bysupervisingphysician.IndicatesPAorPACaftername.OutofstateRx
forlegendandCSdrugsmaybefilledinWA.
Pharm.D.,B.S. DoctorofPharmacy; RCW18.64;WAC Mayprescribe(initiateormodifytherapy)inaccordancewithapproved
Pharm.,B.Pharm., BachelorofSciencein 246863100 protocolaspartofcollaborativepracticeagreement.Samelimitsforhisorher
R.Ph. Pharmacy;Bachelorof protocolastheauthorizingprescriber.MusthaveDEAnumbertoprescribe
Pharmacy249;Registered CSAs.Mayadministerprescribeddrugsanddevices.
Pharmacist
Pod.D. DoctorofPodiatrysee RCW18.22 SamescopeasM.D.iftreatingorperformingsurgeryonfeetorankles.
D.P.M.

149
WILLIAME.FASSETT

R.D.H. RegisteredDental RCW18.29 Mayapplytopicalprophylacticagents(e.g.,fluorides),topical
Hygienist antimicrobials,ortopicalanestheticstoteethandgums.Noprescriptive
authority.Mustpracticeundersupervisionofadentist.
R.N.,B.S.N.,M.N.,M.S.N., RegisteredNurse; RCW18.79 NoprescriptiveauthorityunlessalsoanARNP.Mayadministerdrugs
D.N.P. BachelorofScience orderedforhisorherpatients.TheNursingCareQualityAssurance
inNursing,Master Commissionhasdeterminedthatnursesmayrestockremotedrug
ofNursing;Master dispensingdevices.250PublichealthRNsmaydispensecertaindrugs,
ofSciencein accordingtoNCQAC.ManyARNPsholdeithertheM.N.orM.S.N.
Nursing;Dr.of degrees,andtheD.N.P.(DoctorofNursingPractice)degreeisintended
NursingPractice tobecometheprimarygraduatedegreefornursepractitionersand
nurseclinicians.NurseswhoarenotARNPsorCRNAsmayconveya
prescribersorderbutcannotbedelegatedtoprescribeorauthorize
refills.
R.T.,R.R.T.,RespiratoryCare Respiratory RCW18.89 NowlicensedasRespiratoryCarePractitionersinWashington.May
Practitioner Therapist; administerprescribedrespiratorydrugs.
Registered
Respiratory
Therapist
R.V.M.C.;R.V.T. Registered RCW19.92.30; R.V.M.C.mayperformdispensingtasksunderdirectsupervisionofa
Veterinary WAC246935, veterinarian,andmaydeliververifieddrugstoaclient.R.V.T.may
MedicationClerk; 937 administerveterinarydrugsunderdirectorindirectsupervisionof
Registered veterinarian.
Veterinary
Technician
*AcademicdegreesareinBOLDITALIC.**SeealsoRCW69.41.030andRCW69.50.101(w)
PRESCRIBINGAUTHORITYMAYNOTBEDELEGATED,UNLESSSPECIFICALLYPROVIDEDINSTATUTE.Asthe
BoardofPharmacynotedin2009,Validprescriptionsmustbesigned,eithermanuallyorelectronically,bya
practitionerwithprescriptiveauthoritytheactofsigningaprescriptioncannotbedelegated.Aregistered
nursemayprepareaprescriptionformanualorelectronicsignature,buttheprescribingpractitionerisalways
responsibleforensuringthattheprescriptionconformsinalltheessentialelementstothelawand
regulations.251
ItisimportanttorecognizethatapharmacistprescribingunderprotocolinWashingtonhasnotbeen
delegatedanyauthoritybythepractitionerwhoapprovestheprotocol.Theauthoritytoprescribeunder
protocolispartofthescopeofpracticeofapharmacist(seeabovediscussionofhowthepharmacistshould
issueaprescription).
WHEREOTHERWISEALLOWEDBYLAW,ANURSEORSTAFFMEMBERMAYCOMMUNICATEAPRESCRIPTIONTO
THEPHARMACISTATTHEPRESCRIBERSREQUEST.Whenatelephonedprescriptionorrefillreauthorizationis
allowed,anurseordesignatedstaffmembermaycommunicatetheordertothepharmacistatthedirectionof
theprescriber.
Apharmacistengagedinpracticeataclinicmaycommunicateordersonbehalfofaprescriberjustascanany
otherstaffmember.Asnotedabove,itisimportantthatapharmacistdoingsoclearlydistinguishhisorherrole
asanagentasopposedtoaprescriberunderprotocol.Thepharmacistwhoiscommunicatingtheorder
doeshaveanopportunitytoreviewtheorderpriortoitstransmission,anditwouldbereasonabletoassume
thathisorherresponsibilitiesinthiscasearesimilartothoseofthepharmacistsreceivingtheorder(ofcourse,
thereceivingpharmacistmayhaveadditionalknowledgeaboutprescriptionsfromotherprescribersthatthe
transmittingpharmacistdoesnothave).
AsnotedinChapter3,apharmacistornurseinalongtermcarefacilityorhospicemayactastheagentofthe
prescriberinenteringverbalordersinachartand/orincommunicatingorderstoapharmacy,withoutanyprior
formalagencyrelationshipwiththeprescriber.
150
DECEASEDORDISCIPLINEDPRESCRIBER.Whatbecomesofhisorherprescriptionswhenaprescriberloseshis
orherlicenseordies?Obviously,noprescriptionswrittenafterthelossofalicensecouldbevalid,and
prescriberscannotissueprescriptionsfromthegrave(therehavebeencaseswhereadeceasedphysicians
widowcontinuedtotrytooperatehispracticeafterhisdeath).InWashington,however,itappearsthat
prescriptions,whenwrittenbyanauthorizedprescriber,arevaliduntiltheylegallyexpire,eveniftheprescriber
subsequentlyloseshisorherlicensetopractice.Becauseapatientcannolongerobtaincarefromapractitioner
whenthatpractitionerisnotlicensed,butaprescriptionpreviouslywrittenbythatpractitionerisstillvalid,
then,byextension,thereisalsonobasistoinvalidatethepreviouslyissuedprescriptionsofapractitionerwho
dies.
AformerexecutivedirectorofWashingtonsBoardofPharmacywaspubliclyonrecordthatprescriptionsdie
withtheprescriber,andthatwhenaprescriberloseshisorherlicense,theprescriptionssheorhepreviously
wrotenowbecomeinvalid.However,whentheexecutivedirectorprovidedtestimonyinastatecourtcriminal
trialthataphysicianspreviouslywrittenprescriptionsbecomeinvalidwhenthatphysicianloseshisorher
license,theWashingtonAppealsCourtsubsequentlyopinedthatTheStateconcedesthatthisopinion'doesnot
appeartobeexplicitlysupportedinstatutorylaw,'andindeed,thereisnoWashingtonauthorityfor[the
executivedirectors]statement.(Statev.Clausing,104Wn.App.75,86,15P.3d203(2001))TheWashington
SupremeCourtsubsequentlydeclaredthattheexecutivedirectorsopinionwasanerroneousone...(Statev.
Clausing,149Wn.2d620,629,56P.3d550(2002)).(Beawarethatotherstates,suchasOregon,dodealwith
thisissueexplicitlyinregulation.)
However,IFAPATIENTPRESENTSANEWORREFILLPRESCRIPTION,ANDTHEREAREPROBLEMSWITHTHE
PRESCRIPTIONTHATPRECLUDEDISPENSINGTHEMEDICATIONUNTILTHEYARERESOLVED,thepharmacist
cannotconsultwithadeadorunlicensedprescriber,andwillneedtolocatealicensedpractitionercurrently
caringforthepatienttoresolvethem.
IfapatienthasaneworrefillableprescriptionthatisnotexpiredunderWashingtonlaw,andthereareno
problemsrelatedtotheprescriptionthatneedtoberesolvedinordertoprovidethepatientwith
pharmaceuticalcare,thepharmacistmayconsidertheprescriptionvalid.
Ineverycase,thebestpracticeforapharmacisttofollowisonethatASSURESCONTINUITYOFPATIENTCARE;
makingsurethatpatientsremaininappropriaterelationshipswithcurrentlylicensedpractitioners,butatthe
sametimenotcausingthepatienttogowithoutnecessarymedication.
ISSUEDINTHEDUECOURSEOFMEDICALPRACTICE(RCW69.41.040)
LegenddrugsmustbeprescribedinthecontextofaBONAFIDEPRESCRIBERPATIENTRELATIONSHIP.Priorto
issuingaprescription,forexample,theprescribermusthaveconductedanappropriateexaminationand
maintainedproperrecords,andmadeaprofessionaljudgment.
PRESCRIPTIONSTHATARESOLDTOPATIENTSARENOTVALID.Forexample,Internetprescribingseldom
involvesabonafidepatientprescriberencounter.Likewise,prescriptionmillswherepatientspaytohave
prescriptionswritten(oftenforCSAs)donotproducevalidprescriptionsthatapharmacistcanlawfullydispense.
INTERNETPRESCRIPTIONSAREGENERALLYINVALID.Prescriptionswrittenbyphysiciansonthebasisofan
Internetquestionnairefilledoutbythepatientaregenerallyinvalid,becausethereisnoactualexaminationof
thepatientinvolved.
RYANHAIGHTONLINEPHARMACYCONSUMERPROTECTIONACTOF2008.InOctober2008,Congresspassed
PublicLaw110425,namedafterRyanHaight,ahighschoolseniorinLaMesa,CA,whodiedin2001following
151
WILLIAME.FASSETT
ingestionofVicodinobtainedfromanonlinepharmacyinOklahoma.Theactprohibitsthedeliverydispensingor
distributionofacontrolledsubstanceviatheInternetunlessitispursuanttoaprescriptionissuedbya
practitionerwhohasconductedatleastoneinpersonphysicalexaminationandevaluationofthepatientwithin
theprior24months.ItalsorequiresInternetpharmaciestoregisterwiththeDEApriortoengaginginInternet
pharmacyinvolvingcontrolledsubstances(seechapter5).
TREATMENTOFPARTNERSFORSEXUALLYTRANSMITTEDDISEASESEXPEDITEDPARTNERTHERAPY.A
physicianmayprescribeantibioticstotreatapatientwithChlamydiaorgonorrhea,andissueaprescriptionfor
thepatientspartner,eventhoughthepartnerhasnotbeenexamined.ThisactivityisknownasExpedited
PartnerTherapy(EPT),252andisconsideredacceptableandethicalmedicalpractice,becausewithouttreatment
ofthepartner,thepatientislikelytobecomereinfected.Thebenefitsoftreatingthepartnermaybeseento
outweightheriskofadverseeffectsarisingfromalessthanidealprescribinganddispensingsituation.The
WashingtonMedicalQualityAssuranceCommissionhasissuedapolicystatementacknowledgingthe
appropriatenessofsuchprescribingundercertaincircumstances.253Underthispolicy,thebonafidephysician
patientrelationshipisconsideredestablished,sotheprescriptionsarevalid.TheMQAChasalsoalloweda
specialprescribingprotocolwherebypartnerpacksmaybedistributedbypublichealthclinicstaffwithouta
prescription,providedtheindividualcaseisreviewedbyalicensedprescriberwithin7days.254
Inaccordancewiththispolicy,publichealthclinicsinWashingtondistributepartnerpackswhichmayormay
notcontainthepartnersnameonthelabel.CountyHealthDepartmentsinmanycountiesdistributethese
partnerpacksfreethroughparticipatingcommunitypharmacies.Notallcountyhealthdepartmentsprovide
theseservices,however.AsofFebruary2015,distributionofpartnerpacksthroughpharmaciesisavailableinall
countiesexceptFerry,PendOreille,andStevenscounties.InSkamaniaCountythepacksareavailable,butfrom
theHealthDepartmentonly.Awebsiteisavailableforpatientsandphysicianstolocateparticipating
pharmacies.255ThePharmacyCommissionhasprovidedinputtotheDepartmentofHealthonthisprogramand
hasencouragedpharmacisttocontacttheirlocalpublichealthclinicformorespecificinformationonthespecial
prescribingprotocolforpartnerpacks.256
EvenwhenprescriptionsarewrittenforEPToutsideofsuchaprotocol,thepharmacistisjustifiedindispensing
theseprescriptionsinoutpatientpharmaciesifcertainstepsaretaken.
Importantly,unlessthepatients3rdpartypayerspecificallyallowsit,donotchargea3rdpartyforthe
partnersmedication.
Determineasbestaspossiblewhetherthepartnerhasanyconditionsorallergieswhichwouldpreclude
useofthedrug.
Advisethepatienttotellthepartnertoconferwithapharmacistorphysicianbeforetakingthedrugif
thepartnerhasdrugallergiesorisonanymedication.
Inmanycases,theprescriberdoesnotknoworindicatethepartnersnameontheprescription.This
createsaproblemunderWashingtonlaw,whichrequiresthatthenameofthepersonreceivingthedrug
mustbeontheprescription.However,thePharmacyCommissionhasgiventacitapprovaltothe
DepartmentofHealth'sprotocolusingpartnerpacks.Areasonablepolicywouldmirroronepreviously
approvedinColorado:
o Prepareaseparatecontainerforthepartnersmedication.
o Labelthepatientsprescriptionwiththepatientsname
o Labelthepartnersprescriptionwiththepartnersname,ifknown,orwiththepatientsname
followedbyPartner(e.g.,JordanSmithsPartner).
o Issueaseparateprescriptionnumberforeachprescription.
152
MUSTBEWITHINTHESCOPEANDAUTHORITYOFTHEPRESCRIBER.Apodiatristcannotprescribemedications
forcongestiveheartfailure,eventhoughankleedemamaybearesultofCHF.Adentistcannotnormally
prescribebirthcontrolpills.Likewise,somepractitioners,suchasoptometrists,arenotabletoprescribe
ScheduleIIdrugsinmoststates(except,asinWashington,hydrocodoneproducts).Veterinarianscannot
prescribedrugsforhumans,andMDscannotprescribedrugsforcatsordogs.Apharmacistwhoknows,or
shouldknow,thataparticularprescriptionisnotwithinthescopeorauthorityoftheissuingprescriberhasa
correspondingresponsibilitynottofilltheprescription.Thepharmacistmustbeaware,however,ofcurrent
trendsinuseofdrugsbythevariouspractitionerswhonormallyprescribeforhisorherclients.Ifindoubt,ask
theprescribertofillyouinonhowtheyintendthedrugtobeused,soyoucanhelptheclientunderstanditsuse
better.
ISSUEDFORALEGITIMATEMEDICALPURPOSE
Drugsusedfornonmedicalpurposesincludestimulantsforrecreationaluseorandrogensforweighttraining.
Nonlegitimatedruguseisagreaterproblemwithcontrolledsubstancesthanwithlegenddrugs.Nevertheless,if
apharmacistknowsorshouldknowthatthedrugisbeingusedforanonmedicalpurpose,heorsheisnot
authorizedtodispensetheproduct.
ANABOLICSTEROIDRESTRICTIONS.Specificstatutoryprohibitionsexistagainstprescribing,administering,or
dispensingsteroids,oranyformofautotransfusion,forthepurposeofmanipulatinghormonestoincrease
musclemass,strength,orweight,ortoenhanceathleticabilityunlessmedicallynecessary(e.g.,runners
anemia).Steroidsinclude
Anabolicsteroids
Androgens
Humangrowthhormone(RCW69.41.300310)
ThePharmacyCommissionhaslistedbyregulationparticulardrugsthatconstitutesteroids(WAC246
883040).
RESTRICTIONSONSCHEDULEIISTIMULANTSSEECHAPTER5.
FEDERALRESTRICTIONSONHUMANGROWTHHORMONE.Aspecificfederalstatuteestablishescriminal
penaltiesforofflabeldispensingofhumangrowthhormone(HGH,rhGH,somatropin).21U.S.C.333(e))makes
itacrimetoknowinglydistributeHGHforuseinhumansotherthanthetreatmentofadiseaseorother
recognizedmedicalcondition,wheresuchusehasbeenauthorizedbytheSecretaryofHealthandHuman
Servicesundersection355of[Title21]andpursuanttotheorderofaphysician.AlthoughtheFDAmaynot
initiateactionagainstprescribers,dispensershavebeensubjecttoprosecutionandatleastonespecialty
pharmacyissubjecttoadeferredprosecutionagreementwiththeJusticeDepartmentrelatedtoitsdispensing
ofsomatropinforofflabeluses.Theapprovedindicationsare:PediatricpatientsGHdeficiencyleadingto
shortstatureorgrowthfailure,Turnersyndrome,idiopathicshortstature,SHOXdeficiency,failuretocatchupin
heightaftersmallforgestationalbirth;AdultschildhoodonsetoradultonsetGHdeficiency.A2015Indiana
courtopinionheldthatspecialtypharmacieshadnodutytodispensesomatropinprescriptionswhenthey
refusedfromagoodfaithbeliefthattheprescriptionswerenotforapprovedindications.257Pharmacistsare
entitledtoknowthediagnosisorindicationforasomatropinprescriptionbeforedispensing.
OFFLABELUSES.Drugsmaybeprescribedforusesnotincludedintheirpackageinsert;thisisnotthesameas
issuingaprescriptionforotherthanalegitimatemedicalpurpose.TheFDCAprohibitsmanufacturersfrom
promotingdrugsforofflabeluse,butdoesnotrestrictthepracticeofmedicineunderstatelaw,withcertain
exceptionssuchasHGH(seeabove).WhendispensingaprescriptionwrittenforanonFDAapprovedindication,
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WILLIAME.FASSETT
thepharmacistshouldbeawareoftheintendeduse,andtheliteraturesupportingit.Thepharmacistmust
distinguishbetweenuseofthedrugforaconditionnotlistedinthepackageinsertandprescribingofdosesthat
areoutsidethenormalrangeforthedrugwhenmakingprofessionaljudgmentsabouttheappropriatenessof
theprescriptionforthepatient.ResourcesavailabletoevaluateofflabelusesincludetheAmericanHospital
FormularyService(AHFS)andtheUSPDI.(Seechapter8regardingofflabelusesandMedicaidorMedicare
prescriptions.)
TheFDAhasfiledcriminalandcivillawsuitsagainstmanufacturersortheiremployeeswhohavepromoted
prescriptiondrugsforofflabeluses.However,thesuccessfulcriminalmisdemeanorprosecutionofa
pharmaceuticalsalesrepresentativeforpromotingXyrem(gammahydroxybutyrate)forofflabeluseswas
overturnedbytheUSCourtofAppealsfortheSecondCircuitonthebasisthatthesalesmansstatementswere
freespeechprotectedbytheFirstAmendment.258
LEGIBLE.WrittenprescriptionsinWashingtonmustbelegible.RCW69.41.120requireswrittenprescriptions
tobelegible.RCW69.41.010(13)definesalegibleprescriptionascapableofbeingreadandunderstoodby
thepharmacistfillingtheprescriptionorthenurseorotherpractitionerimplementingthemedicationorder.A
prescriptionmustbehandprinted,typewritten,orelectronicallygenerated.Thisstatuteisinterpretedto
declareprescriptionsordrugorderswrittenincursivetobelegallyillegible.Pharmacistswhofillillegible
prescriptionswithoutverifyingtheprescriptionareliablefordamagescausedtotheirpatients.Thebeststrategy
fordealingwithaprescriptionincursivehandwritingistocalltheprescribertoverifyit,andindicateonthe
prescriptiontheverifiedorder.
TAMPERRESISTANTPRESCRIPTIONPADS.
FORMEDICAIDRECIPIENTS.AprovisioninanomnibusIraqWarandKatrinaRecoveryappropriationsbill259
requiresWRITTENPRESCRIPTIONSISSUEDFORMEDICAIDRECIPIENTStobeexecutedontamperresistant
prescriptionpads.CMShaspublishedafactsheetforpharmacists.260
Aqualifyingprescriptionpadcontainsthefollowingelements:
Oneormoreindustryrecognizedfeaturesdesignedtopreventcopying;
Oneormoreindustryrecognizedfeaturesdesignedtopreventerasureormodification;and
Oneormoreindustryrecognizedfeaturesdesignedtopreventuseofcounterfeitforms.
Theruledoesnotapplytooralprescriptions,faxedprescriptions,orelectronicprescriptions,ortorefillsof
prescriptionswhichwereissuedpriortotheeffectivedate(June2006).
TRANSFERREDMEDICAIDPRESCRIPTIONS.WhenreceivingtransferredprescriptionsforMedicaidpatients,the
receivingpharmacistmustconfirmfromthetransferringpharmacistthattheprescriptionwaswrittenon
tamperresistantpadorwasexempt.
NONCOMPLYINGPRESCRIPTIONS.Pharmacistsmayfillnoncomplyingprescriptionsinemergenciesaslongas
confirmationfromtheprescriberisreceivedbyfax,phone,oremailwithin72hours.Pharmacistshould
documentthetimeofdaydispensedinthetimeofdaythatconfirmationisreceived.
Pharmacistsmayconfirmnoncomplyingprescriptionswiththeprescriber,eitherverballyorbyfax,ifthe
confirmationisreceivedbeforetheproductisdispensedtothepatient.Theexacttimeofdaythatthe
confirmationisreceived,andthattheproductisdispensed,shouldbedocumented.
PharmaciesthatdispenseMedicaidprescriptionspursuanttononqualifyingprescriptionsaresubjectto
rejectionoftherelatedMedicaidclaimandsanctionsimposedunderfederallaw.
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ALLPRESCRIPTIONSISSUEDTOPATIENTSINWASHINGTONSTATEmustconformtothesametamperresistant
prescriptionpad(TRPP)requirementsasMedicaidprescriptions.261However,thepadsmustprintedon
approvedpaperandmustbearaPharmacyCommissionsealofapproval.(RCW18.64.500(7))TheBoard
announcedinJanuary2010thatthesealwillconsistofamapoftheStateofWashingtonwithamortarand
pestleinthecenter.Totherightofthegraphic,thetextwillreadPaperApprovedbytheWashingtonState
BoardofPharmacy.TheprocessforapprovalofpaperisavailableontheCommissionswebsite.262The
Commissionin2016beganaprocesstoredesigntheseal,andtomakechangesincludingnolongerrequiring
thermochromicink,andallowingapprovedplainpaperprintingtechnology/solutions.Implementationwillbe
inMarch2017.263
TRPPsarerequiredforallprescriptionsthatarehandwrittenbytheprescriber(forbothlegenddrugsand
controlledsubstances)fordeliverytoapharmacy,exceptfor:
Prescriptionsthataretransmittedtothepharmacybytelephone,fax,oreprescribed;or
Prescriptionswrittenforpatientsinhospitals(inpatientoroutpatient),residentsofLTCfacilitiesor
hospiceprograms,inpatientsorresidentsofmentalhealthfacilities,orincarceratedindividuals,where:
o Theorderiswrittenbytheprescriberorauthorizedagent(inthecaseofLTCfacilitiesorhospice
programs)intothepatientsmedicalorclinicalrecord,
o Theorderisgivendirectlytothepharmacy,and
o Thepatientneverhastheopportunitytohandlethewrittenorder.(RCW18.64.500(9))
ThestatutespecifiesthatAllactsrelatedtotheprescribing,dispensing,andrecordsmaintenanceofall
prescriptionsshallbeincompliancewithapplicablefederalandstatelaws,rules,andregulations.(RCW
18.64.500(10)).ThestatutegivestheCommissionauthoritytoissueregulationstoimplementitsrequirements.
PrescriptionswrittenoutsideofthestateofWashingtonbyauthorizedprescribersarenotcoveredbythese
rules,butmustconformtorulesinthestatewherewritten.
TIMELIMITSONPRESCRIPTIONS.Prescriptionsmusthavebeenwrittennomorethanoneyearpriorto
thedateoffillingorrefilling,andnomorethansixmonthspriorinthecaseofprescriptionsforcontrolled
substancesinschedulesII,III,IVorV.ThegeneraloneyearlimitonlegenddrugsfoundinPharmacyCommission
regulationsthatspecifythatnoprescriptioninWashingtonmayberefilledbeyondoneyearfromthedate
written.(WAC246869100(2)(d))Thisrulenecessarilymeansthataprescriptionmaynotbeinitiallyfilledmore
thanoneyearafterthedateitwaswritten.Aspecificruleplacinga12monthlimitonprescriptionsappliesto
homeIVtherapydrugs.(WAC246871050(1))Thelimitoncontrolledsubstancesisfoundinthefederal
ControlledSubstancesActandinRCW69.50.308(d)and(f)(seeChapter5).
OTHERREQUIREDELEMENTS.Otherelementsthatmustbeontheprescriptionoravailabletothe
pharmacistaredescribedinthefollowingparagraphs.
DATEWRITTEN
Theprescribermustplaceontheprescriptionthedateheorsheactuallyissuedtheprescription.Predatingor
postdatingprescriptionsrenderstheprescriptionsinvalid.Whenthedateisinadvertentlyenteredimproperly,
thepharmacistmaycontacttheprescribertocorrectthedate.Forexample,prescriptionsissuedinJanuary
ofteninadvertentlyindicatethepreviousyear.Thepharmacistmaynotsimplyassumethisisanerror,however,
butmustconfirmwiththeprescribertheactualdatetheprescriptionwasissued.Inthecaseoflegenddrugs,a
confirmationwiththeprescribersofficeoragentshouldbesufficient,buttocorrectdatesonacontrolled
substanceprescriptionrequiresadirectconversationwiththeissuingprescriber(seeChapter5).
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WILLIAME.FASSETT
THEPATIENTSADDRESSmustbeontheprescriptionoravailableinpatientmedicationrecord,arecordbook,or
hospitalorclinicrecord.(WAC246869100(2)(a))Thedefinitionofaddressasitappliestothepatientisnot
clearunderfederallaw.And,frankly,somepatientsdonthaveahome.Theonlydescriptionunderfederallaw
ofanaddressiscontainedintheUSPostalServiceDomesticMailManual,whichindicatesthatthedelivery
addressspecifiesthelocationtowhichtheUSPSistodeliveramailpiece.TheDMMindicatesthatforstreet
andnumberthesendershallIncludetheapartmentnumber,orusethepostofficeboxnumber,orgeneral
delivery,orruralrouteorhighwaycontractroutedesignationandboxnumber,asapplicable.Thus,itappears
thatunderfederallawthepatientmayprovideanylocationtowhichtheUSPScoulddelivermail.Itisacommon
practicefortheMedicaidprogramtouseaphysiciansofficeaddressastheaddressforahomelessMedicaid
recipient.
TheWApatientmedicationrecordregulationsdefinetheaddresstobeusedinthemedicationprofileasthe
placeofresidenceofthepatient,butasimilardefinitionisnotsetforthforWAC246869.(WAC246876010)
PDMPADDRESSES.WashingtonsrulesfordataenteredinthePrescriptionDrugMonitoringProgram(see
chapter5)requirethefollowingforpatientaddress.
Patientaddressthecurrentgeographiclocationofthepatientsresidence,or,ifthepatientaddressis
incareofanotherpersonorentity,thatpersonsorentitysaddressisthepatientaddress.Ifmore
thanoneispossible,theyshouldberecordedinthefollowingorderofpreference:
Geographicallocationofresidence,aswouldbeidentifiedbya911locator;
AnaddresslistedbytheUSPostalService;or
Thecommonnameoftheresidenceandtown(WAC246470010(6))
DIRECTIONSFORUSE.WAC246875020(h)requiresthatthepharmacistrecordinanautomatedpatient
medicationrecordsystem,Thecompletedirectionsforuseofthedrug.Thetermasdirectedisprohibited
pursuanttoRCW18.64.246and69.41.050.Thus,WashingtondoesnotallowapharmacisttorecordUD
(fromtheLatin,utdictumasdirected)instructionsasthedirectionsforaprescriptioninanautomatedpatient
medicationrecordsystem.(Note,however,thatthisrequirementisnotspecifiedformanualrecordsystemsin
WAC246875030).Thus,forthepharmacisttosatisfythisrule,theprescriptionmustcontaincomplete
directions.Ifnot,thepharmacistmustascertainthedirectionsfromtheprescriber.
Otherlawsandrulesaremorespecificconcerningdirectionsforuse,includingthestatutoryrequirementsfor
prescriptionsdispensedfromemergencydepartments(seeChapter3).
DEALINGWITHSPECIFICLABELINGSITUATIONS:
PRODUCTSWITHCONSUMERLABELING.Someproductsareclearlylabeledonthecontainer,suchasbirth
controlpills.Inthesecases,UDshouldbeinterpretedtoreadasdirectedonthecontainer.
COMPLICATEDDOSAGEREGIMENS.Somedirectionsareforcomplicateddoses.Theprescribermayhavegivena
writtenscheduletothepatient,suchasinstepdowndosingofprednisone.Insuchacase,thepharmacistneeds
toknowwhatthoseinstructionswere,todeterminecompliance.Thepharmacistshouldmakeacopyofthe
instructionsandattachthemtotheoriginalprescription,andusethemtoestimateadayssupply.The
directionswouldthenbeinterpretedasTakeaccordingtowrittensheetprovidedbyphysician.Ifappropriate,
anottoexceedlimitshouldbespecifiedonthelabel.
DRUGREQUIRINGDOSAGEADJUSTMENT.Sometimesthepatientisgiventhedrug,andtoldtoconfirmthe
dosagewiththeprescriber,orwilltakedifferingdosesinaccordancewithmonitoringoftherapy,asin
treatmentwithCoumadin.Insuchcases,thedirectionsshouldbeinterpretedastakeona[daily]basisin
accordancewithconsultationwith[provider].Maximumdosingshouldbespecifiedifappropriate.Pharmacists
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whomanagewarfarintherapyinanticoagulationclinicsroutinelyprovidethepatientwithaprintedsheet
showingspecificdosesonspecificdaystobetakenuntilthenextappointmentorotherchange.
INSTRUCTIONSREGARDINGGENERICSUBSTITUTION.Thisisautomaticwithtwolineprescriptionblanks,butthe
informationneedstobegatheredspecificallyontelephonedorders,andrecordedonthefaceofthe
prescriptionbythepharmacist.(RCW69.41.120).
Prescriptionswrittenbygenericname(ortelephonedbygenericname)donotcomeundertherequirementsof
thesubstitutionlaw.
RXNUMBER,DATEOFFILLING,PHARMACISTID.Thepharmacistmustplaceaserialnumber,thedateof
dispensing,andtheinitialsoftheresponsiblepharmacistonthefaceoftheprescription.(WAC246869
100(2)(c)).
NDCOFDRUGPRODUCTDISPENSED.Inallcaseswhereproductinterchangehasoccurred(seebelow),the
pharmacistmustrecordtheidentityoftheactualdrugdispensedontheprescriptionandinthepatientrecord.
(RCW69.41.120)ThisismosteasilyandclearlydonebyrecordingtheNationalDrugCode(NDC)oftheproduct
dispensed.Notethatforpurposesofidentifyingthedrugproductanddosageform,onlythefirst2NDCfields
(manufactureranddrugproduct)mustberecorded.Thethirdfield,whichrecordsthepackagesizeisrequired
tosubmitclaimstothirdpartypayers,andmustmatchtheactualpackagedispensed(seeChapter8).
TELEPHONEDORORALPRESCRIPTIONS.Pharmacistsmayreceiveoralortelephonedprescriptionsfor
legenddrugs.Acopyofanoralprescriptionmustbemaintainedinthepharmacyrecords.(RCW69.41.120(4),
RCW69.50.308(2)(d),21CFR1306.21(a))Itisimportantforthepharmacisttorecordthefullnameofthe
personcommunicatingtheprescription,withenoughdetailtounambiguouslyidentifythepersonincaseoflater
inquiry.(SeealsoChapter7sectiononriskmanagement).
VOICEMESSAGESYSTEMS.Commissionrulesallowforrecordingofprescribersverbalprescriptionsin
pharmacieswithapprovalfordifferentialhours(seeChapter3),subjecttotherequirementthatthepharmacist
mustbetheonetoplaybackthemessage,andthevoicemessagesystemmustinformthecallerofthe
pharmacyshoursofoperation.264TheFDAhaspublishedacompliancepolicyguidethatconsidersarecorded
oralprescriptionasmeetingtherequirementsintheFDCAofanoralprescription,ifthepharmacistplays
backtherecordingandconcludesthatthevoiceheorshehearsisthatofaphysicianknowntothepharmacist,
andthereisnoobviousreasonforsuspectingtheauthenticityoftherecordedprescription.265ThisCPG,issued
in1980,seemsbasedonanarchaicmodelofcommunitypharmacypractice.
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WILLIAME.FASSETT
BESTPRACTICESFORVERBALPRESCRIPTIONS.Pharmacy
CommissionandotherDepartmentofHealthstaffhave DEPARTMENTOFHEALTH
developedguidelinesfortransmissionofverbal GUIDELINES:
prescriptionstoapharmacist(seesidebar).266 BESTPRACTICEGUIDELINESFOR
2IDNATIONALPATIENTSAFETYGOAL.Nationalpatient VERBALPRESCRIPTIONS
Whencallinginaprescriptiontoapharmacist,the
safetystandardsnowadvocatethatkeypatientcare
followinginformationshouldbeprovided:
recordelementsuseatleast2uniquemeansofidentifying
(2ID)thepatient,suchasthepatientname,telephone PatientInformation
number,dateofbirth,and/ormedicalrecordnumber.This Name,includingmiddleinitial(spelllast
isincludedinTheJointCommissionsNationalPatient nameifunusual)
SafetyGoalsfor2017(NPSG01.01.01).267Asthe Dateofbirth
Commissionsuggestedinitsguidelines,obtainingatleast Phonenumber
2identifierswhenreceivingverbalordersshouldbe
DrugInformation
standardofpracticeforpharmacists.
Drugname
FACSIMILETRANSMISSION(FAX).Ingeneral,faxesof Strength
legenddrugsweretraditionallytreatedasiftheywere Dosage
telephonedorders.Recently,however,statelawhas Directions(dose&frequencyof
beguntotreatfaxesasaseparateentityfromverbal administration)
orders,andfaxesarespecificallynotconsideredaformof Routeofadministration
electroniccommunicationofprescriptioninformation. Quantity
SeeRCW69.41.010(10)andRCW69.50.101(n).268 Refills,ifany
Notationofpurpose,ifappropriate
Thelegislature269hasrevisedRCW18.64.245tospecify Ifgenericsubstitutionispermitted
thatwhenapharmacyreceivesaprescriptionindigitalor
electronicformatthroughfacsimileequipment PrescriberInformation
transmittinganexactvisualimageoftheprescription,... Name(wholename,withidentifier,ifa
thedigitalorelectronicrecordofeverysuchprescription commonname)
dispensedatthepharmacyconstitutesasuitablerecordof Nameofclinicorpractice
prescriptions,providedthattheoriginalordirectcopyof DEAnumberifappropriate
theprescriptioniselectronicallyordigitallynumberedor Nameandroleofcaller,ifotherthan
referenced,dated,andfiledinaformthatpermitsthe practitioner
informationrequiredtobereadilyretrievable.(RCW Phonenumberwherepharmacistcancheckback
18.64.245(2)).Thismeansthatanelectronicfilecopyofa withtheprescriberifthereareanyquestionsabout
faxmaybestoredinthecomputer. theprescription
Informationconcerningeachprescriptionmustincludeall
theinformationspecifiedbelowforelectronicprescriptionsgenerally,asapplicable.
TheCommissionhasspecifiedthefollowingrequirementsforfaxesforlegenddrugsprescriptionsorrefill
authorizationssentdirectlyfromtheprescribertothepharmacy.(WAC246870050):
Mustcontainthedate,time,andtelephonenumberandlocationofthetransmittingfaxmachine.
Thepharmacistisresponsibleforassuringthatthefaxwillbelegiblefortwoyears(i.e.,notprintedon
thermalpaper).
SeeChapter5forrulesforfaxingcontrolledsubstancesprescriptions.
158
TransmissionofrefillinformationfromPHARMACYTOPHARMACYmaybefaxed.
WhatifthefaxisacopyofaprescriptiononaTAMPERRESISTANTPADthatwhenfaxeddisplaysVOIDor
ILLEGAL?Suchafaxeffectivelyrenderstheprescriptionunfillableandwillrequirefollowupand,ifpossible,
conversiontoanoralprescription.TheCommissionhasrecommendedthatpantographsontamperresistant
padsshouldstateCOPYorCOPY/faxinsteadofVOIDorILLEGAL.
ELECTRONICPRESCRIPTIONS.
Thelawallowsforelectronictransmissionofprescriptions,(RCW69.41.055)andpermitstheBoardtoadopt
specificrules(WAC246870).Thelawrequiresthefollowing:
Transmissionisdirectlyfromtheprescribertoapharmacyofthepatientschoice,withnointervening
personhavingaccesstotheinformation.(Thisprohibitsordersbeingtransmittedthroughaninsurance
company.)Anagentoftheprescriberinalongtermcarefacilityorhospiceprogramisnotan
interveningpersonunderthisrule.
TheCommissionmustapprovethesystemsforsendingandreceivingtheinformation.
Theinformationmustincludeanexplicitopportunityforprescriberstocommunicatepreferences
regardinggenericsubstitution,butdoesnotlimittheabilityofpractitionersorpharmaciestopermit
substitutionbydefaultunderapriorconsentauthorization.
Thepharmacistincharge(responsiblepharmacymanager)shallestablishorverifyproceduresand
policiestoensureintegrityandconfidentialityoftheprescriptioninformation.
o Allmanagers,employees,andagentsofthepharmacymustread,sign,andcomplywiththe
establishedprocedures.
Thepharmacistmustexerciseprofessionaljudgmentregardingtheaccuracy,validityandauthenticityof
thedrugorderstransmittedelectronically.
ElectronicstorageofdigitalorelectronicprescriptionsmeetstherecordkeepingrequirementsofRCW
18.64.245,providedthatsuchrecordsareelectronicallyordigitallynumberedorreferenced,dated,
andfiledinaformthatpermitstheinformationrequiredtobereadilyretrievable.
TheCommissionpublishesalistofAPPROVEDSYSTEMS270onitswebsite.Rulesgoverningthesesystemsare
containedinWAC246870060.
COMMISSIONRULESFORELECTRONICPRESCRIPTIONS.TheCommissionhasadoptedadditionalrulesinWAC
246870.Anelectronicallytransmittedprescriptionmustincludethefollowingelements.Electronic
prescriptionslackingtheseshouldbeverifiedwiththeprescriberandtreatedastelephonedprescriptionsafter
verification.
Prescribersnameandaddress
PrescribersDEAnumberforCSAprescriptions
Dateofissuance
Patientsnameandaddress
Drugname,dose,route,form,directionsforuse,quantity
Electronic,digital,ormanualsignatureoftheprescriber
Refillsorrenewalsauthorized,ifany
Aplacetonoteallergiesandanotationofpurposeforthedrug
Indicationofapreferenceforgenericsubstitution.
Otherrequirementsofthelaw
IdentificationoftheelectronicsystemreadilyretrievableforPharmacyCommissioninspection.
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WILLIAME.FASSETT
Thepharmacistisresponsibleforverifyingthateachelectronicprescriptionisvalidandshallverifythe
authenticityoftheprescriptionwiththeprescriberifthereisaquestion.
Therecannotbeanexclusiveagreementconcerningfaxedordersbetweenthepharmacyandthe
prescriber.

DRUGPRODUCTSELECTION
Thepolicyissuesrelatedtotheselectionofadrugproducttomeetaphysiciansprescriptionarealmostentirely
economic,andrelatedtobalancingtheneedfornewdrugs,andhencetheneedforincentivesforinnovation,
withthegoalofmakingdrugtherapyaffordable.However,modernpolicyhasemergedfromearlierpolicythat
wasconcernedwithprotectingthepublicagainstpharmacistsmistakesincompounding,aswellasthe
possibilitythatapharmacistwouldsubstituteaninferioringredientinsteadoftheoneintendedbythe
prescriber.
ACCURATEDISPENSING.Thepharmacistisrequiredtodispensetheproductandstrengthcalledforinthe
prescription.TheCommissionmaydisciplineapharmacistorinternwhohascompounded,dispensed,or
causedthecompoundingordispensingofanydrugordevicewhichcontainsmoreorlessthantheequivalent
quantityofingredientoringredientsspecifiedbythepersonwhoprescribedsuchdrugordevice.(RCW
18.64.160(5))
Whenadrugisprescribedbyitsofficialorgenericname(e.g.,ibuprofentablets800mg),theprescriberhas
leftittothepharmacisttodeterminetheparticularmanufacturerorsourceoftheproduct,secundumartem
(accordingtotheart[oftheapothecary]).
Whenadrugisprescribedbybrandname(e.g.,Motrintablets800mg),itisunderstoodthattheprescriber
intendsaparticularproductfromaparticularmanufacturer.
Moststatesallowgenericsubstitution,andmanyprovidefortherapeuticsubstitution.Thesetwoactivitiesfallin
thecategoryofdrugproductselection,sometimescalledproductinterchange.Whenallowed,product
interchangedoesnotexposepharmaciststochargesofmisfillingprescriptionswhentheyuseadifferent
manufacturersproduct.
BRANDVERSUSGENERICDRUGS.
THEINNOVATORPRODUCT.AllnewdrugsmarketedintheUSmustbesubjecttoanapprovedNEWDRUG
APPLICATION(NDA)approvedbytheFDAThemanufacturerwhoisfirstgrantedanNDAissaidtobethe
innovatorofthedrug,andgenerallyhaspatentrightsgrantingitexclusiveprivilegestosellthedrugfora
definedperiodoftime(typically17yearsfromthedatethepatentisfiled).Sinceitmaytakeseventotenyears
todevelopapatentedNewChemicalEntity(NCE)afterapatentisobtained,themarketingexclusivitymaylast
foraslittleassevenyearsaftertheNDAisapproved.CertainprovisionsofthePrescriptionDrugMarketingAct
(PDMA)andtheOrphanDrugandPatentRightExtensionActallowforextensionofmarketexclusivity.
160
When,asaresultofPhaseIVexperience,amanufacturerwishestochangeinformationinthepackageinsert
(e.g.,newindications,changeddirections,additionalwarnings,etc.),aSUPPLEMENTALNEWDRUGAPPLICATION
(SNDA)isfiledwiththeFDA.Totheextentthatthesechangesresultfrompatentableinnovations,theinnovator
maygainadditionalmarketexclusivityforthenewclaims.
OFFICIALNAME.Allapprovednewdrugsaregivenanon CAPITALIZATIONOFDRUG
proprietaryname,whichintheUSisofficiallycalledthe
UNITEDSTATESADOPTEDNAME(USAN),approvedbythe
NAMES
USANCommission,adivisionoftheDepartmentofCommerce. BRANDNAMESarepropernouns,and
Themanufacturerslabelofallapproveddrugsmustinclude shouldbeCapitalized(unlessthe
theUSAN,andthemanufacturermayalsomarketthedrug manufacturerhaschosentodo
underaproprietary,ortradename. otherwise,asinella).
TRADENAMESarethepropertyofthemanufacturerwhocoins GENERICNAMESarenotpropernouns
them,subjecttofilingwiththePatentOffice.Thetradename andarenotcapitalized,unlesstheterm
maybeeitherregisteredasindicatedbythesymbol,or isthebeginningofasentenceorlist.
trademarked,asindicatedbythesymbol.The
EXAMPLES:
manufacturerslabelmustpresentthenonproprietaryname
inlettersatleasthalfashighasthetradename.Pharmacists Soma(carisoprodol)
labelingprescriptioncontainersmayalwaysusethe Pradaxa(dabigatranetexilate)
nonproprietaryname,andmayalsousethetradenameaslong Lantus(insulinglargine[rDNAorigin]
astheproductinthecontainerismadebythemanufacturer injection)
whoownsthetradename. ella(ulipristalacetate)
ENFORCEMENTOFCOPYRIGHT.Themanufacturerisrequired Examplechartnote:Currentdrugs:
bycopyrightlawtoenforceitsrightstoatradenameby hydrochlorothiazide25mgqd,Pradaxa
challengingincourtanyinappropriateuseofthetradename 150mgbid,ramipril10mgqd,
byothers.Fromtimetotime,drugcompanieshavefiled omeprazole20mgqd,CentrumSilver1
lawsuitsagainstpharmacistswhousedtheirtradenameson qd
packagesofdrugscontainingagenericproduct,challenging
phrasessuchasibuprofensameasMotrinoribuprofengenericMotrin.Somepharmacylawexperts
recommendthefollowinglanguageonprescriptionlabelstoavoidtrademarkinfringementsuits:ibuprofen
substitutedforMotrin.
PATENTEXPIRATION.Afterthepatentrightsexpireonaparticulardrugproduct,othermanufacturersmay
marketgenericproductsthatarethesamechemicalentityasindicatedintheNDA,providedtheymeet
requirementsforbioavailabilityandbioequivalence.Primarily,thegenericequivalentmustprovidethesame
pharmacokineticparameters,Cp,TpandAUC,astheinnovatorsproduct,asdemonstratedbyinvivotesting.
ThegenericmanufacturerdoesnotneedtorepeattheinnovatorsPhaseIthroughPhaseIIItesting,butonlythe
morelimitedproofofbioavailabilityandbioequivalence.ThesearedocumentedinanAbbreviatedNewDrug
Application(ANDA).AftertheFDAapprovestheANDA,thegenericmanufacturermaydistributetheproduct
underitsnonproprietary(generic)name,and/ormaydevelopabrandnameofitsownfortheproduct.
HATCHWAXMANACT.In1984,CongresspassedtheDRUGPRICECOMPETITIONANDPATENTTERM
RESTORATIONACT271withtheintentionofspeedingtheadoptionandapprovalofgenericdrugs.Itiscommonly
calledtheHatchWaxmanAct,afteritscongressionalsponsors,Sen.OrrinHatch(RUtah)andRep.Henry
Waxman(DCal).ThetitleoftheActsuggestsitwasamatterofcompromise:ithopedtoincreasecompetition
161
WILLIAME.FASSETT
yetatthesametimeextendedpatentprotectionstocertaindrugs.TwomajorsectionsoftheActdealwith
thesegoals:
ANDAS.TheActclarifiedandstandardizedtheprocessbywhichagenericmanufacturermayseektomarketa
genericdrug,byfilinganANDA.
PATENTISSUES.
TheActprovidesforupto5yearsofpatentextensionforcertaincategoriesofnewdrugstocovertimespentin
drugdevelopmentafterthepatentwasissued.TheActalsoprovidedameansbywhichagenericmanufacturer
couldchallengethepatentstatusoftheinnovatorsproductwithoutrunningtheriskoflengthypostmarketing
patentinfringementlawsuits.
EachinnovatormustfilewiththeFDAalistofthepatentsitclaimsprotectitsrighttomarkettheproduct.These
patentsarelistedbytheFDAinTheOrangeBook(seebelow).
ThefirstgenericcompetitortofileanANDAmay,undersection505(j)(5)(B)(IV)oftheAct,fileasocalled
ParagraphIVnoticethatitiscontestingtheinnovatorspatent.Thistriggerstwoprovisions:
Iftheinnovatorfilesasuitwithin45daystochallengethegenericapplication,thentheinnovatoris
awardeda30monthextensionofitspatent.
ThefirstgenericmanufacturertofileasuccessfulANDAgainsa180dayexclusiverighttomarketthe
drug,andtheFDAwillnotapproveanotherANDAforthesameproductduringthatperiodofexclusivity.
ALLEGEDABUSEOFHATCHWAXMANPROVISIONS.Bytheearly2000sitbecameapparenttomanythat
innovatorsweretakingadvantageoftheParagraphIVprovisionstoundulyextendtheirmarketingexclusivity,
largelybyprotectingtheirdrugswithextrapatentsofpoorquality,filinglawsuitstoprotectthepatentseven
whenthelawsuitwillbelost,butgettingtheextramarketexclusivityanyway.272Inaddition,manufacturers
havebeguntoenterintoavarietyofschemeswithpotentialgenericcompetitors.Strategiesusedtoavoid
genericcompetitionhaveincluded:
Filingofadditionalpatentsbasedonsuchthingschangesinthecrystallinestructureoftheactive
pharmaceuticalingredient.
Filinglastminutechangestotheinnovatorsproductlabeling.
Enteringintoagreementsforauthorizedgenericsand/orpayfordelaycontractswherethegeneric
manufactureragreestodelaybringingitsproducttomarketinreturnforreversepaymentsfromthe
innovator.
IMPACTONPHARMACIES.Ingeneral,theseissuesaffectmanufacturersonly,anddonotaffectpharmacistswho
dispenseordistributegenericdrugsthataresubjecttoanANDA.Themajorexceptioniswhenpharmacists
attempttopreparebyextemporaneouscompoundingaproductthatissubjecttoanexistingpatent.(See
sectiononcompounding)
BIOSIMILARSVERSUSGENERICS.Themajordifferencebetweengenerics,whicharetherapeuticallyequivalent
andchemicallyidenticalsmallmolecules,andbiosimilars,isthatbiosimilarsaretypicallynotmolecularly
identical,buthavebeenshowntobehighlysimilartothereferenceproduct,withonlyminordifferencesin
theclinicallyinactivecomponentsofthemolecule,andnoclinicallymeaningfuldifferencesbetweenthe
biosimilarandthereferencedrug.
NONPROPRIETARYNAMES.Inaddition,wheregenericsallhaveexactlythesamenonproprietaryname,the
nonproprietarynameofabiosimilarproductmaycontainasuffixdesignatingthemanufacturer.Forexample,
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Neupogenisthereferencefilgrastimproduct,whilethenonproprietarynameforZarxioisfilgrastimsndz.
Similarly,thebiosimilarforRemicade(infliximab)isInflectra(infliximabdyyb).
RELATEDBIOLOGICALPRODUCTS.Somepotentiallyinterchangeablebiosimilarsmaynotbeapprovedviathe
biosimilarapprovalprocess;Granix(tbofilgrastim)wasapprovedusingtheNDAprocess;itisconsidereda
relatedbiologicalproducttoNeupogen,anditsnonproprietarynameincludesaprefix(e.g.,tbo).
GENERICANDBIOSIMILARSUBSTITUTION
DRUGVERSUSBIOLOGIC.Inthisdiscussion,Iwillusedrugtorefertoasmallmoleculedrugapprovedbyan
NDAorANDA,andbiosimilartorefertoabiologicdrugproductapprovedbyanNDA,aBLA,ora351K
interchangeabilityapplication.
Virtuallyallstatesprovideforgenericsubstitution,wherebythepharmacistmayormustdispensethegeneric
drug,evenwhentheprescriberprescribestheproductbyitstradename.Thepurposeofalltheselawsisto
providesavingstoconsumers,ortothirdpartypayers(suchasstateMedicaidprograms).Manystates,including
Washington,requirethatallorasignificantpartofthesavingsarisingfromgenericsubstitutionbepassedonto
thepurchaser.Generally,thepharmacistmusthavesomeevidencethatthegenericproductisanapproveddrug
productthathasbeenfoundbioequivalenttotheinnovatorsproduct.Similarly,pharmacistsmusthave
evidencethatapotentialbiosimilarproductisapprovedforinterchange.
InWashington(RCW69.41.100180),thepharmacistmayuseanyinformationregardinggenericequivalencyhe
orsheconsidersreliable.Otherstatesspecifyoneormoreofseveralresourcesorliststhatthepharmacistcan
ormustconsult.
Todeterminebiosimilarinterchangeability,Washingtonrequiresthatpharmacistsconsultapositiveformulary
orlistingprovidedbyFDA,oracopyofthelistthatispostedontheCommissionwebsite.However,thecurrent
listingontheCommissionwebsitehastypicallylaggedbehindthepostingsbyFDA(seePurpleBook,below).
PHARMACISTSGENERICSUBSTITUTIONREFERENCESOURCES
Inallstates,aprescriptionwrittenbygeneric(nonproprietary)namepermitsthepharmacisttochoosethe
sourceoftheproduct,whetheritisbioequivalenttoabrandnamedrugornot.
ORANGEBOOK
TheOrangeBookisofficiallyentitledApprovedDrugProductswithTherapeuticEquivalents273andis
publishedbytheFDA.TheonlyproductslistedaredrugswithNDAsand/orANDAs.Noneoftheunapproved
drugsdiscussedabovearelisted.
EQUIVALENCYDETERMINATIONS.Drugsareconsideredequivalentiftheyareapproveddrugswiththesame
ingredientanddosageform,andgenerallyproducethestatisticallyequivalentAUCandCmaxwhencomparedto
thereferencedrug.Ifforvariousreasonsacomparisonbetweenagenericandthereferenceproductcannotbe
done,theproductscannotberated.Thus,anOrangeBookratingofABcanbetakenasevidenceoftherapeutic
equivalence,butotherratingsdonotprovenonequivalence.
EQUIVALENCYRATINGS.DrugsthatareconsideredtherapeuticallyequivalentaregivenanArating;thosethat
arenotareratedB.Asecondletterisappendedtoindicatethebasisfortherating,andallgenerically
equivalentproductsareratedAB.Ineverycase,theratingofagenericdrugisrelatedtoaspecificinnovators
product.Insomecases,twoinnovatorsproductshavethesamechemicalingredient,butarenot,themselves,
bioequivalent.Thisismostoftenthecasewithsustainedreleasepreparationsthatusedifferentformulationsto
achievetheirreleasecharacteristics.Forexample,AdalatCCandProcardiaXLeachcontainnifedipineHCl.
However,theyusedifferentformulations,andarenotinterchangeableasgenerics.AdalatCCisratedAB1and
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WILLIAME.FASSETT
ProcardiaXLisratedAB2.GenericnifedipineformulationsthatareinterchangeablewithAdalatCCarerated
AB1,andthosethatcanbesubstitutedforProcardiaXLareratedAB2.
LEVOTHYROXINEproductshaveposedaspecialproblem,andtheFDAusesfourratingsAB1,AB2,AB3,andAB4.
Someproductsareratedinmorethanonecategory.Forexample,herearetheNovember2014ratingsfor25
mcglevothyroxineproducts:
SynthroidisratedAB1andAB2
LevoxylisratedAB1andAB3
LevoTisratedAB2andAB3
LevothroidisratedAB4
UnithroidisratedAB1,AB2,andAB3
Levothyroxine(MerckKGAA)isratedAB2,AB3
Levothryroxine(Mylan)isratedAB1,AB2,AB3,andAB4
Currently,Mylanslevothyroxinein25mcgstrengthmaybesubstitutedforanyoftheothernamed
products,andcarefulmatchingoftheremainingproductsshowsthattheymayallbeinterchangedfor
oneanother,withtheexceptionofLevothroid.
POSITIVEFORMULARIES.Somestatesdonotallowthepharmacisttosubstituteanyequivalentgeneric,but
requirethepharmacisttochoosefromdrugsonaspecificlist.Thislistisoftencalledapositiveformulary.
SomestatesspecifytheOrangeBookastheirpositiveformulary,whileothershaveaspecialcommissionthat
developsthelist.WashingtonallowsthepharmacisttochoosefromsourcesinadditiontotheOrangeBook,so
Washingtondoesnotrequireapositiveformulary.However,theOrangeBookisreferredtoinWAC246899
030(b)asaboardapprovedreferenceforapositiveformularyoftherapeuticallyequivalentproductswithinthe
limitsstatedinthatpublication.
NEGATIVEFORMULARIES.Afewstateshavelistsofdrugsthatcannotbesubstituted.Manyoftheselistsinclude
socallednarrowtherapeuticindexdrugs,suchaslevothyroxine,warfarin,digoxin,andfurosemide.Thedrugs
placedontheselistsareoftenplacedthereasaresultofapoliticalprocessinwhichmanufacturersand
physicianshavelobbiedtolimitgenericsubstitution.Washingtondoesnotspecificallyprecludegeneric
substitutionbyuseofanegativeformulary.274
BIOSIMILARINTERCHANGEABILITYREFERENCETHEPURPLEBOOK:Theequivalencyevaluationguidefor
biologicalproductsthatcorrespondstotheOrangeBookisthePurpleBook,officiallyentitledListsofLicensed
BiologicalProductswithReferenceProductExclusivityandBiosimilarityorInterchangeabilityEvaluations.This
listing,whichisupdatedquarterlybyFDA,consistsofatableshowingalllicensedbiologicalproducts,and
whethertheyarebiosimilar(designatedbyaB)and/orinterchangeable(designatedbyanI).AsofJanuary
2017,theFDAhasnotyetdesignatedanyproductsasinterchangeable.Asnotedabove,newreference
biologicalproductsaregranted12yearsofdataexclusivitybeforeaninterchangeablebiosimilarmaybe
approved.AdraftguidanceforindustryonhowtodemonstratetoFDAthatabiologicalproductis
interchangeablewithareferenceproductwasissuedforcommentonJanuary17,2017.275
PHARMACISTCOMMUNICATIONTOPRESCRIBERWHENINTERCHANGINGBIOSIMILARS.UntilAugust1,2020,
RCW69.41.193requiresthatapharmacistinterchangingabiologicalproductmustassurecreationwithin5days
ofanelectronicrecordaccessibletothepatientspractitionerthatprovidestheexactbiosimilardispensed,using
thenameoftheproductandmanufacturer,ortheNDCcode.Therecordmaybeplacedinasystemthatis
accessiblethrough:
Aninteroperableelectronicmedicalrecordssystem;
164
Anelectronicprescribingtechnology;
Apharmacybenefitmanagementsystem;or
Apharmacyrecordaccessibletothepractitioner
Sucharecordispresumedtoprovidenoticetothepractitioner.Alternatively,thepharmacistmay
communicatethisinformationdirectlytothepractitionerusingfax,phone,electronictransmission,orother
prevailingmeans.
Thesecommunicationsarenotrequiredwhen:
Theprescribedproducthasnointerchangeablebiologicalproductequivalent;or
Thedispensingwasarefillwithnochangeinproductfromthepriorfilling;or
Thepharmacistorthepharmacistsdesigneeandthepractitionercommunicatedbeforedispensing
andthecommunicationincludedtherequiredinformation.
DAWINSTRUCTIONSANDSPECIALPRESCRIPTIONBLANKS.
Moststatesallowprescriberstopreventdrugproductselectionorinterchangeonaperprescriptionbasis.Some
willallowtheprescribertoindicateDispenseAsWrittenorDAWinwritingontheprescription.Othersallow
acheckbox(DAW).Washington,likeseveralotherstates,requiresatwolineprescriptionblank,withone
signaturelineindicatingSubstitutionPermittedandtheotherindicatingDispenseAsWritten.In
Washington,manufacturerssuccessfullylobbiedtohavetheDAWlinebeontherighthandsideoftheblank,
reasoningthatmanyrighthandedphysicianswould,byforceofhabit,preferentiallysignthatline.Under
Washingtonlaw,aprescriptionthatiswrittenbyaWashingtonprescriberisnotvalidunlessitiswrittenona
twolineprescriptionblank.InWashington,pharmacistsarerequiredtoobtainandrecordspecificinstructions
regardingsubstitutionwhenreceivingtelephonedprescriptions,andtoindicatethisonthepermanentrecord
(WAC246899020(a))
DEALINGWITHOUTOFSTATEPRESCRIPTIONS.Accordingtothestatute,Washingtonpharmacistsmay
substitutethegenericproductorinterchangeablebiosimilaronanoutofstateprescriptionwrittenbybrand
nameunlessotherwiseinstructedbytheprescriberthroughtheuseofthewordsdispenseaswritten,words
ofsimilarmeaning,orsomeotherindication.However,theCommissionhasqualifiedthisrequirementinWAC
246899050.Ifthepractitionerhasnotclearlyprovidedinstructionsregardingsubstitution,thepharmacistmay
substituteagenericonlyifthepharmacisthasdeterminedsubstitutionispermittedbyoneofthefollowing
means:
Thepharmacisthaspersonalknowledgeoftherulesinthestateoforigin;or
Thepharmacisthasobtainedauthorizationfromtheprescriber;or
Thepharmacistobtainscurrentinformationontherulesintheotherstatefrom
o TheWashingtonPharmacyCommission
o TheBoardofPharmacyintheotherstate
o Someotherreliableprofessionalmeans.
GENERICSUBSTITUTIONISREQUIREDINWASHINGTON.Washingtondoesnotallowthepharmacisttodispense
abrandnameifsubstitutionispermittedexceptwhen:
Thepharmacydoesnothaveagenericproductinstockwhichis,inthepharmacistsprofessional
judgment,bioequivalenttothedrugprescribed;or
Thepatientorthepatientsagentrequeststhebrandedproduct,andtheproductisnotbeingpaidfor
bypublicfunds.
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WILLIAME.FASSETT
BIOSIMILARINTERCHANGEISREQUIREDINWASHINGTON.
RCW69.41.125specifiesthatthepharmacistmustsubstituteaninterchangeablebiologicaldrugproductthathe
orshehasinstockifsubstitutionpermittedisindicatedontheprescription,unless:
theprescribedbiologicalproductisrequestedbythepatientorthepatientsagent,or
thewholesalecostoftheinterchangeablebiologicaldrugproductisnotlessthantheprescribed
biologicalproduct.
SAVINGSMUSTBEPASSEDONTOPURCHASERINWASHINGTON.
Washingtonlawrequiresthat60%ofsavingsresultingfromgenericsubstitution(butnotbiosimilarinterchange)
bepassedontotheconsumer.Washingtonisoneof17stateswithsomerequirementtopassonatleastsome
ofthesavings.276Thecalculationshouldbemadeasfollows:

0.6
Iamnotawareofany
enforcementofthisruleby
PHARMACYCALCULATIONSINALAWTEXTBOOK!
theCommissionoranyother EXAMPLE:Yourpharmacysnormalcashpriceforabrandnamedrugis$85.00for90
groupinWashington. tablets.TheAverageWholesalePrice(AWP)forthisproductis$83.00per100.Your
However,attorneysfor ActualAcquisitionPrice(AAC)fromthewholesalerisAWPless18%forthisdrug(or
consumersinotherstates 82%ofAWP).YourAACforthegenericequivalentis$41.00per100.Whatisthe
havefiledclassactionsuits maximumpriceyoucanchargethepatientfor90tabletsunderWAlaw?
forconsumerfraudwhen $ $
90 0.82 90 $24.35
pharmacistshavefailedto
followspecificregulations $85.00 $24.35 0.6 $70.39

andtheycanshoweconomic
damages.277Oneofthe Aslongasyourpharmacyschargeforthegenericislessthan$70.39,yourpharmacy
willbeincompliancewiththisstatutoryrequirement.
collateralissuesthatarisesis
howtocalculatethe Forthisexample,thepharmacysgrossmarginonthebrandnamedrugis27.9%
pharmacysusualand ($23.75/$85.00100%);themarginongenericdrugis47.5%($33.49/$70.39100%),
customarypriceforthedrug.
Ifthepharmacyhasadiscountprogramthatisgenerallyopentothepublic,thediscountedpriceforthebrand
namedrugwilldetermineitsusualprice.
NOTICETOPUBLIC.RCW69.41.160requiresthefollowingnoticestobedisplayedtothepublicinevery
pharmacy(thecontentofthissignwasrevisedin2015toincludebiologicalproducts):
UnderWashingtonlaw,alessexpensiveinterchangeablebiologicalproductorequivalentdrugmayinsome
casesbesubstitutedforthedrugprescribedbyyourdoctor.Suchsubstitution,however,mayonlybemade
withtheconsentofyourdoctor.Pleaseconsultyourpharmacistorphysicianformoreinformation.
PHARMACISTJUDGMENTPROTECTED.PharmacistsareprotectedbyRCW69.41.170frombeingcoercedby
employerstodispenseaparticulargenericdrugortosubstituteagenericdrugforanotherdrug.
Interchangeablebiosimilarsarenotincludedinthissectionofthestatute.
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NOGREATERLIABILITY.Physiciansandpharmacistsareprotectedfromliabilityforauthorizingordispensing
genericdrugs.(RCW69.51.150)
Apractitionerwhoauthorizesaprescribeddrugshallnotbeliableforanysideeffectsoradverse
reactionscausedbythemannerormethodbywhichasubstituteddrugproductisselectedor
dispensed.
ApharmacistwhosubstitutesatherapeuticallyequivalentdrugproductpursuanttoRCW69.41.100
through69.41.180asnoworhereafteramendedassumesnogreaterliabilityforselectingthedispensed
drugproductthanwouldbeincurredinfillingaprescriptionforadrugproductprescribedbyits
establishedname.
ApharmacistwhosubstitutesapreferreddrugforanonpreferreddrugpursuanttoRCW69.41.190[i.e.,
underthePreferredDrugList]assumesnogreaterliabilityforsubstitutingthepreferreddrugthan
wouldbeincurredinfillingaprescriptionforthepreferreddrugwhenprescribedbyname.
ApharmacistwhoselectsaninterchangeablebiologicalproducttobedispensedpursuanttoRCW
69.41.100through69.41.180,andthepharmacyforwhichthepharmacistisprovidingservice,assumes
nogreaterliabilityforselectingtheinterchangeablebiologicalproductsthanwouldbeincurredinfilling
aprescriptionfortheinterchangeablebiologicalproductwhenprescribedbythesamename.The
prescribingpractitionerisnotliableforapharmacistsactoromissioninselecting,preparing,or
dispensinganinterchangeablebiologicalproductunderthissection.
THERAPEUTICSUBSTITUTION
Therapeuticsubstitutioninvolvesdispensingadruginthesametherapeuticclassasthebrandprescribed,but
notofthesamechemicalentity;thiswouldalsoapplytodispensingabiosimilarthathasnotbeendeclared
interchangeable.Acommonexamplewouldbeuseofatorvastatin(Lipitor)whentheprescriptionwasissued
forsimvastatin(Zocor).Therapeuticsubstitutioncouldalsoincludedispensingofagenericequivalentthatis
notofthesamedosageformordeliverysystemasthedrugprescribed,suchasusingAdalatCCinplaceof
ProcardiaXL.Thekeyelementisthatthecontrolofthepatientssymptomsisequivalentonceadjustments
havebeenmadefordosageand/ordosingintervals.Itisnormallyassumedthattherapeuticinterchangesare
madeinsuchawayastoavoidadditionaladverseeffects.Therapeuticinterchangeisoftenperformedto
providethedrugofchoice,asindispensingamoxicillinwhenampicillinhasbeenprescribed(toimprove
absorptionandavoidGIeffects).Thedrivingforcebehindmosttherapeuticinterchange,however,istoachieve
drugcostsavings.Washingtonlawallowstherapeuticsubstitutionwheneverthepharmacisthasobtainedprior
authorizationfromtheprescriber,andisnotexplicitabouthowthisauthorizationmustbeobtained,in
contrasttotherulesregardinggenericsubstitution.Thepharmacistmayexercisetherapeuticsubstitutionunder
thefollowingcircumstances:
WITHPRIORAUTHORIZATION(Washingtonrequiresdocumentationtobeavailableinthepharmacyrecords
WAC246899030(3).)Ifapharmacyhasreceivedpermissionfromaprescriber,orgroupofprescribers,to
performtherapeuticsubstitutionforagivenclassofdrugs,andhasarecordofthatpermission,thentheymay
undertakethatsubstitutionforalloftheprescriberspatientsunlessinstructedotherwiseonanindividualbasis.
ThereisnorequirementunderWashingtonlawthatthepriorauthorizationbeinwriting,althoughitmustbe
documentedinthepharmacyrecords.Apriorauthorizationlog,recordingthedatesandtimeswhen
individualprescribersgrantedpriorauthorization,wouldbeoneapproachtomeetingtherequired
documentation.Ingeneral,however,writtenapprovalwillbepreferredformanyreasons.
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WILLIAME.FASSETT
SPECIFICAUTHORIZATIONONANINDIVIDUALPRESCRIPTION
Anytimetheprescriberhasindicatedontheprescriptionthatsubstitutionofanotherdruginthesame
therapeuticclassmaybeundertaken,thatwillallowthepharmacisttoperformthesubstitutionforthat
prescription.
VIACOLLABORATIVEPRACTICEAGREEMENT(inthiscase,thepharmacistisnotperformingtherapeutic
interchangeasmuchasisprescribingadifferentdrug.)
INACCORDANCEWITHTHETHERAPEUTICINTERCHANGEPROGRAMANDPREFERREDDRUGLIST(RCW
69.41.190;WAC18250200.)
ATherapeuticInterchangeProgram(TIP)isrequired,usingaPreferredDrugList(PDL),inallstatefundeddrug
programs,includingMedicaid,LaborandIndustries,andtheUniformMedicalPlan(UMP)forstateemployees.
TheWashingtonHealthCareAuthority(HCA)administerstheprogram.ThecurrentPreferredDrugList278is
updatedfrequentlyontheRxWashingtonwebsite.
ThePharmacy&TherapeuticsCommitteethatdeterminesthePDLiscomposedof10members(4physicians,4
pharmacists,1PA,1ARNP).
ATHERAPEUTICINTERCHANGEPROGRAM(TIP)isestablishedbythelegislation.Thisprogramwentintoeffectin
mid2004,andpharmacistsdispensingprescriptionsthatarepaidforbyastateprogramareauthorizedand
requiredtoperformtherapeuticsubstitutionusingdrugsonthePDL,whereanonpreferreddrughasbeen
ordered.Thestatutewassignificantlyrevisedin2009.279
ELIGIBLEPRESCRIPTIONSMUSTBEHAVEBEENWRITTENBYANENDORSINGPRACTITIONER.HCAmaintainsa
database280toidentifyendorsingpractitioners.TheendorsingpractitionermayindicateDAWthedrugwill
NOTbesubjecttohimpriorauthorization,butwillforUMPrecipients(seebelow)besubjecttoTier3pricing.
ThisDAWdoesnotrelatetogenericsubstitution,whichisindicatedbyasignatureonatwolineblank,but
mustbespecificallywrittenontheprescription.
AUMPrecipientmayrequestDAW,andpaytheTier3price,ifthedrugiscovered.
PRESCRIPTIONSWRITTENBYNONENDORSINGPRACTITIONERSaretreatedasfollowsbyeachstatefunded
program:
UniformMedicalPlan(PPO):Thepharmacistcannotmakeasubstitution,evenforagenericequivalent.
Thepatientwouldreceivethenonpreferreddrugasprescribed,atahighercost.
L&I:Anonendorsingpractitionerdoesnotqualifyforthe"dispenseaswritten"exemptionandthenon
preferreddrugwouldnotbepayableunlessthepharmacistorpractitionercallswithmedical
justification.
Medicaid:ThepharmacistisrequiredtocontactACStorequestthenonpreferreddrugandshow
medicaljustification.
SUBSTITUTIONSARETOBEMADEFROMWITHINTHESAMETHERAPEUTICCLASS.
REFILLSOFCERTAINTYPESOFDRUGSARENOTSUBJECTTOSUBSTITUTION
Antipsychotics
Antidepressants
Antiepileptics
Chemotherapy
Antiretrovirals
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Immunosuppressives
Immunomodulator/antiviraltreatmentforhepatitisCforwhichanestablished,fixeddurationoftherapy
isprescribedforatleasttwentyfourweeksbutnomorethanfortyeightweeks.
NOTIFICATIONTOPRESCRIBER.Whenasubstitutionismade,thepharmacistshallnotifytheprescriberofthe
specificdruganddosedispensed(canbebyfax,etc.)
CONTROLSONEXCESSIVEEXCEPTIONSTOENSUREECONOMICDRUGUSE.
ProgramsmayimposelimitedrestrictionsonendorsingprescribersauthoritytowriteDAWprescriptions,
underthefollowingconditions:
ThereiscleardataorstatisticalevidencethattheprescriberspatternofuseofDAWdiffersfromhisor
herpeers;
Theprogramdirectorhas
o Presenteddatatotheendorsingpractitionerindicatinghisorherdeviationfrompeernorms,
o Providedtheendorsingpractitionerwithanopportunitytoexplainthevariation,and
o Ifthevariationhasnotbeenexplained,hasgiventhepractitionersufficienttimetochangehis
orherprescribingpatterns.
Therestrictionsmustbelimitedtotheextentnecessarytoreducevariation,andonlyuntilthe
practitionercandemonstrateareductioninvariationinlinewithhisorherpeers.
Refillsofantipsychoticsandotherlisteddrugsmaynotberestricted.
Agenciesmayimmediatelydesignateanavailablegenericasthepreferreddruginapreviouslyreviewed
therapeuticclasswithoutP&Tcommitteereview.ProgramsmaydesignateanavailableequallyeffectiveOTC
alternativeasapreferreddrug.
LimitedrestrictionsmaybeimposedonendorsingpractitionersoptionstospecifyDAWforapatientsfirst
courseoftherapywithinatherapeuticclass,when:
Thereisalessexpensiveequallyeffectivetherapeuticalternativegenericproductavailabletotreatthe
condition;
TheDURboardhasreviewedandprovidedrecommendationsastotheappropriatenessofthe
limitation;
Theendorsingpractitionerretainstheopportunitytorequestthebranddrugasamedicallynecessary
firstcoursetreatment;
Theprogrammayprovideavailableprescription,emergencyroom,diagnosisandhospitalizationhistory
totheendorsingpractitioner;and
Foranyantipsychoticrestrictions,theprogramshalleffectivelyguidegoodpracticewithoutinterfering
withthetimelinessofclinicaldecisionmaking.DSHSpriorauthorizationprogramsmustprovidefor
responseswithin24hoursandatleasta72houremergencysupplyoftherequesteddrug.
OfflabeluseofbrandnamedrugsmaybesubjecttorestrictionsonuseofDAWbyendorsingpractitioners
when:
Thereisalessexpensive,equallyeffectiveonlabelproductavailabletotreatthecondition;
TheDURboardhasreviewedandprovidedrecommendationstotheappropriatenessofthelimitation;
Theendorsingpractitionershallretaintheabilitytorequesttheofflabeldrugasmedicallynecessary.

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WILLIAME.FASSETT
REFILLINGANDPARTIALFILLINGOFPRESCRIPTIONS,ANDOTHER
DEVIATIONSFROMQUANTITYREQUIREMENTS
HOWPRESCRIBERSINDICATEREFILLS.Refillsmaybeauthorizedbytheprescriberatthetimethe
prescriptioniswritten.Theprescribermayindicaterefillsinanumberofways:
MAYBEREFILLEDXTIMES.Inthiscase,thepharmacistmayrefillthedruguptoXtimes,inthesame
quantityastheoriginal.
MAYBEREFILLEDTHROUGHACERTAINDATE.Inthiscasethepharmacistmayrefillthedrugasoftenas
neededinanappropriatequantityuntilthedateshown.
MAYBEREFILLEDPRN.PRNisanabbreviationoftheLatinphrase,prorenata,whichmaybe
interpretedastheoccasionarises,accordingtocircumstances,orasneeded.InWashington,PRN
isdefinedbytheCommissiontoindicateauthorizationforuptooneyearfromthedatetheprescription
waswritten.NoprescriptioninWashingtonmayberefilledbeyondoneyearfromthedatewritten.
(WAC246869100(2)(d))Thisrulenecessarilymeansthataprescriptionmaynotbeinitiallyfilledmore
thanoneyearafterthedateitwaswritten.
REFILLSMAYBEAUTHORIZEDBYTHEPRESCRIBERAFTERTHEPRESCRIPTIONISWRITTEN,typicallyupona
callorelectronicrequestfromthepharmacist.TheCommissionrequirespharmaciestotreatarefill
authorizationoccurringmorethanayearaftertheprescriptioniswrittenasanewprescription,witha
newprescriptionnumber.
DISPENSINGOFREFILLSMUSTBECONSISTENTWITHDIRECTIONS.Inallcasesofrefills,the
pharmacistmustissuerefillsandquantitiesthatareconsistentwiththedirectionsontheprescription.The
pharmacistisresponsiblefornotinganddealingwithbothoveruseandunderuse.Anearlyrefillatonepoint
mustbeconsideredwhenreviewingtheappropriatetimeforrefillatalaterdate.Itisgoodpracticeto
communicatetotheprescriberunusualcircumstancessuchaswhenapatientreportsthelossofdrugsothat
boththepharmacistandprescribermaybecomeawareofpatternspotentialofmisuse.
EARLYREFILLSOFTOPICALOPHTHALMICPRODUCTS.Variationsinhowpatientsselfadministereyedropsmay
causeapatienttousedropsatafasterratethanwouldbepredicted.The2015Legislature281amendedRCW
18.64toallowforoneearlyrefillofaprescriptionfortopicalophthalmicproductswithoutcontactingthe
prescriber,ifallofthefollowingconditionsexist.
Refillisrequestedbypatientatorafter70%ofthepredicteddaysofusebasedonthedateofthe
originalfillorthelastrefill;
Theprescriberhasindicatedontheoriginalprescriptionthataspecificnumberofrefillswillbeneeded
(i.e.,otherthanPRN);and
Therefilldoesnotexceedthenumberofauthorizedrefills.(RCW18.64.530)
EFFECTOFTIMELIMITONREFILLS.Whenarefillistimelimited,thepharmacistmaydispensethefull
originalquantityatanytimepriortotheexpirationdateoftheauthorization.
EMERGENCYSUPPLY.InWashington,apharmacistmaydispenseanemergencysupplyoflegenddrugs:
iftheprescriberisnotavailableandintheprofessionaljudgmentofthepharmacistanemergencyneedforthe
medicationhasbeendemonstrated,thepharmacistmaydispenseenoughmedicationtolastuntilaprescriber
170
canbecontactedbutnottoexceed72hourssupply.Theprescribershallbepromptlynotifiedoftheemergency
refill.(WAC246869100(2)(f)).
NotethatthisparticularregulationappliestoalllegenddrugsinWashington,butbecausethereisnoequivalent
provisionunderfederalrulesforcontrolledsubstances,thisprovisionDOESNOTAPPLYTOPRESCRIPTIONSFOR
CONTROLLEDSUBSTANCES.
Indetermininghowmanydosestogivethepatient,thepharmacistmustestimatehowsoontheprescriberwill
beavailable,anddispenseenoughtolastuntiltheprescriberisavailable,butnotmorethana72hourssupply.
Insomecases,anemergencysupplyofaunitofusepackagemayinvolvedispensingmorethan72hoursworth
ofdrug,suchaswithabronchodilatorinhaler.Ifclearlyneededbythepatientonanemergencybasis,itis
unlikelythattheCommissionwilldisciplinethepharmacist.However,intheeventthatthephysiciandetermines
thatcontinueduseofthedrugdispensedwouldbenotinthepatientsinterest,thepharmacistmustbe
preparedtorecovertheexcesssupplyfromthepatientortotakeotherstepstominimizetherisktothepatient.
Abettersolution:developaprescriptiveauthorityprotocolwithlocalphysicianstoallowthepharmacistto
prescribetheseemergencysuppliestopatientsofthepharmacy.
Thepharmacist,whenfinallycontactingtheprescriber,DOESNOTNEEDTOOBTAINTHEPRESCRIBERS
PERMISSIONTOHAVEDISPENSEDTHEEMERGENCYSUPPLYthepharmacistneedsmerelytoinformthe
prescriberthatthesupplywasgiven.However,THEPRESCRIBERMUSTAUTHORIZEANYADDITIONALREFILLS.
DECLAREDEMERGENCYCONTINUITYOFCAREREFILLAUTHORITY
InadditiontotheprovisionsofWAC246869100(2)(f),apharmacistmayrefillmedicationswhentheGovernor
hasdeclaredanemergencyforaneventwhichpreventscontinuityofhealthcareforpersonsandanimals
becausetheirprescribedmedicationsduetotheemergencyevent.Duringtheperiodofthedeclared
emergencyevent,pharmacistsandpharmaciesmayprovide:
Aninitialsupplyofupto30daysofcurrentprescriptionsforlegenddrugs
Aninitialsupplyofupto7daysofcurrentprescriptionsforcontrolledsubstancesinschedulesIII,IV,or
V.TheCommissionhasdeterminedthatunderadeclaredemergency,controlledsubstancesotherthan
ScheduleIImayalsobesupplied.
Todispenseanemergencysupply,thefollowingconditionsarerequired:
Presentationofavalidprescriptioncontainercompletewithlegiblelabelindicatingthereareremaining
refills,or
Confirmationoftheprescribedmedicationandavailablerefillsbyreviewofthepatientscurrent
medicalrecordsorpharmacyrecords;or
Intheprofessionaljudgmentofthepharmacist;or
Iftheprescriptionisexpiredorhasnorefillsandthepharmacistisunabletoreadilyobtainrefill
authorizationfromtheprescriber,uptoa72hoursupplyasdescribedinWAC246869100(2)(f)orup
toa30daysupplyofmaintenancemedicationmaybesupplied.
Whendispensinganemergencysupplyunderadeclaredemergency,thepharmacistshall:
Documentthedispensingasaprescription,notingthesourceofmedicationinformation(i.e.,container,
prescriber,orpharmacyrecords);
Informthepatientsproviderandthepharmacydispensingtheoriginalsupplyassoonaspossible
followingdispensing;and
Markthefaceoftheprescriptionasanemergencyprescription.(RCW246869105)
171
WILLIAME.FASSETT
PRESCRIBERSCANNOTDELEGATEREFILLAUTHORITYTOSTAFF.Sometimesalocalphysician
maybeplanningavacationandwishestotellhisorherofficestafftookayallrefillstillIcomeback.Thisisan
unlawfuldelegationofauthoritytohisorherstaff,andprescriptionsorrefillsauthorizedbasedonthis
delegationarenotvalid.Apharmacistwhoknowsorshouldknowofthesituationmaybedisciplinedfor
dispensingpursuanttotheseauthorizations.Thephysicianisresponsibletoprovidealternativephysician
coverageforhisorherpatients.However,itispossibleforthephysiciantoestablishacollaborativepractice
agreementwithapharmacisttoallowthepharmacisttoreviewrequestsforrefillsandtoauthorizethemin
accordancewithaprotocol.Thisprotocolcouldallowthepharmacisttoreviewrequestsfrompharmaciesother
thanhisorherownsite.
TheWashingtonNursingQualityAssuranceCommissionreceivedarequestin2007toallowregisterednursesat
aclinictoapproverefillrequestsinaccordancewithaprotocolapprovedbytheclinicphysicians.The
Commissiondeniedtherequest,recognizingtheinabilityofprescriberstodelegatesuchauthoritytonurses.282
TheNursingCommissionhasnotcompletelygivenuponexpandingtheroleofnursesrelatedtodrug
authorizationsunderprotocol,andin2016issuedanopinionthatRNsinpublichealthsettingsmaydetermine
theneedfordrugsandengageindispensingthemtopatientsunderprotocol.283
PARTIALFILLING.
Generally,whenthepatientsinterestsrequire,pharmacistsareallowedtodispenselessthantheprescribed
quantityofmedication,aslongaseachdosageformisofthecorrectstrength.Therearespecialrequirements
forpartialfillingofcontrolledsubstances,butforlegenddrugs,itisgenerallysufficientforpharmacistsmerely
totrackthequantitiesdispensed.Partialfillingoftenoccurswhen:
FORFINANCIALREASONS(includinginsurancecoverage)thepatientdoesntwanttopurchasethefullamount.
Aprescriptionwrittenforlevothyroxine100mcg,#90,canbefilledforanyquantitylessthan90,e.g.,30tablets.
Itmayberefilledinquantitiesof30untilatotalof90havebeendispensed.
WHENTHEPATIENTHASNOTRECEIVEDTHEDRUGBEFOREandisunsurewhetherheorshewilltolerateitorif
itwillmeetthepatientsneeds.
WHENTHEPHARMACYDOESNOTHAVESUFFICIENTMEDICATIONINSTOCK.
BILLINGTO3RDPARTYPAYERSFORPARTIALFILLING.Handlingofoutofstockcreatesproblemswhenthird
parties(especiallygovernmentpayers)aretobebilledforthedrug.Thesepartiesdonotwanttopayforunused
drugordrugthatisnotdeliveredtopatients.Whenpartialfillshavebeenmadewiththeexpectationthat
patientswillpickuptheremainder,andthethirdpartyisbilledforthefullamountduetotransaction
requirements,thethirdpartywillfeeldefraudedifthepatientforgetstopickupthedrug.TheUSgovernment
suedamajorchainoverthisissueandthesettlementwasinthemillionsofdollars.(SeealsoChapter8)
IFPOSSIBLE,3RDPARTIESSHOULDNOTBEBILLEDUNTILTHEFULLQUANTITYHASBEENDISPENSED.
Thepharmacycannotlegallyreusedrugsthathavebeensoldtoapatient,evenifthepatientabandonsthe
drugbynotreturning.Moststates,includingWashington,haveabandonedpropertystatutesthatrequirethat
theabandonedpropertybelongtothestate.
DELIVERINGREMAININGQUANTITYTOTHEPATIENT.Ifthepharmacywantstodeliverormailtheremainderof
theproducttothepatient,thatmayraiseproblemsofmakingdrugsavailabletochildrenorotherswithoutthe
knowledgeofthepatientthatthedrugwastobemailed.
172
Ifpossible,OBTAINTHEPATIENTSWRITTENPERMISSIONTOMAILTHEREMAINDEROFTHEDRUGTOTHEIR
HOMEintheeventthattheyhavenotpickedupthedruginacertainlengthoftime.Somestatesotherthan
Washingtonhaverulesspecificallyprohibitingmailingofdrugstopatientswithouttheirpriorpermission.
SCHEDULEDREFILLSANDMEDICATIONSYNCHRONIZATIONPROGRAMS
Schedulingofpatientsrefillsofchronicmedicationswiththeirpermissionisseenasameanstoimprove
patientadherence,andtoprovidemedicationsinamorecosteffectivemannerthatalsominimizestheamount
ofinventoryapharmacymustkeeponhand.However,concernshavebeenraisedaboutautomaticrefill
systemsthatsimplysendpatientsamonthlysupplyevery30days,bothasasourceoffraud,wasteandabuse,
andofpotentialerror.284Medicareestablishednewpoliciesfor2014requiringMedicarePartDplanstoassure
thatthepatientactuallyneedsagivendrugbeforeanautomaticrefillissent.Thepoliciesweredirected
particularlyatPartDplansthatusemailorderdelivery.Ifthepharmacycannotdemonstratethatthepatient
actuallyneededtherefill,itmaybeexposedtoliabilityunderstateorfederalfalseclaimsacts(seeChapter8).
Medicationsynchronization,althoughsimilartoautomaticrefills,doesmorethansimplysendrefills.The
pharmacyusingasystemsuchastheNCPAsponsoredSimplifyMyMedsprogram,285orthe"AlignMyMeds"
initiativeunderanappointmentbasedmodelpromotedbytheAPhAFoundation,286workstoscheduleallthe
patientscurrentlyneededchronicmedicationstorequirerefillsonthesamedateeithermonthlyorevery90
days.Priortodispensinganyrefills,thepatientiscontactedtodetermineanynoncomplianceorchangesin
medicationssincethelastrefill.AkeyelementoftheAPhAprogram'seffectivenessisthatundermost
circumstances,patientsarescheduledtomakeanappointmentwiththepharmacistatthetimetheypickup
theirmedications.MedicarerequiresthatPartDrecipientsbeabletopayapartialcopaywhenneededto
obtainlessthan30daysupplies,suchaswhenstartingonnewmedicationsorcoordinatingrefillschedules.287
COMBININGREFILLSTODISPENSEALARGERQUANTITY.Itisalongstandingstandardofpractice
thatthepharmacistmaydispensemorethantheamountspecifiedintheprescriptionwhenrefillshavebeen
allowed,andthepatientsinterestswarrantit.Forexample,thephysicianprescribesLipitor10mg,#30,and
labelstheprescriptionRefillPRN.Itisknownandobviousthatifthepatienttoleratestheinitialprescription,
heorshewillbecontinuingtotakethedrugchronically.Iftheinsuranceallowsa90daysupply,thepatientwill
wanttoobtainthedruginthelargerquantitiesonrefills.Usinggoodjudgment,thepharmacistmayreasonably
refilltheLipitorinquantitiesof90,withoutconsultingthephysician.Ifnorefillswereallowed,however,this
wouldnotbepossible.Generally,controlledsubstanceprescriptionscannotberefilledinlargeramountsthan
specifiedontheoriginalprescription.
JUDGMENTISIMPORTANT.Justbecauseadrugisnotacontrolledsubstancedoesnotjustifyrefillinginlarger
quantitiesthanoriginallyspecified.Forexample,apatientwithahistoryofattemptedsuicidemaybeplacedon
tricyclicantidepressantsinquantitiesof10to30tabletsperrefill.Evenifadditionalrefillsareallowed,the
pharmacistmustbecognizantoftherealitythatdispensing100tabletsatasingletimeprovidesthepatientwith
theopportunityoftakingafataloverdose.ExcessiveearlyrefillsofcarisoprodolhaveledtheBoardofPharmacy
todisciplineapharmacist,288and,inatleastonecase,tothedeathofthepatient.
Itisimportanttonote,however,thatnothinginlawrequiresapharmacisttorefillinlargerquantitiesthan
originallyorderedwithoutconfirmingitwiththeprescriber.
Itisalsoimportanttonotethat3rdpartycontractsmayrequirespecificprescriberauthorizationofthequantity
inordertoreceivepayment.
ThePharmacyPracticeActallowsfordispensingof90dayquantitiesofnoncontrolledsubstances,using
judgmentasoutlinedabove.289Undertheseprovisions(RCW18.64.520),apharmacistmaydispenseuptoa90
173
WILLIAME.FASSETT
daysupplypursuanttoavalidprescriptionthatspecifiesaninitialquantityoflessthananinetydaysupply
followedbyperiodicrefillsofthatamountsubjecttothefollowing
Thepatienthascompletedaninitial30daysupplyofthedrug,unlesstheprescriptioncontinuesthe
samemedicationaspreviouslydispensedina90daysupply;
Thetotalquantitydispenseddoesnotexceedthetotalquantityauthorizedbytheprescriber,including
refills;
Theprescriberhasnotspecifiedontheprescriptionthatdispensingtheprescriptionexactlyaswrittenis
medicallynecessary;and
Thepharmacistisexercisinghisorherprofessionaljudgment.
Dispensingagreaterquantityisnotallowediftheprescriberhaspersonallyindicated,orallyorinwriting,no
changetoquantity,orwordsofsimilarmeaning.Aprescribercheckingaboxmarkednochangeinquantity,
mustinitialtheboxorthecheckmark.
Thepharmacistdispensingtheincreasedsupplymustnotifytheprescriber.
Thelawdoesnotcreateanobligationonanyinsureror3rdpartytoallowcoveragefortheincreasedsupply.
DISPENSINGDIFFERENTSTRENGTHSTOACHIEVETHEPRESCRIBEDDOSE.Pharmacistsmay
alsoreasonablydeviatefromtheprescriptionbyprovidingalternatestrengthsifthepatientsinterestsrequire.
Aprescriptionwrittenforprednisone10mgtablets#50,tabletdaily,maybefilledwithprednisone5mg
#100,providedthelabeldirectionscorrectlyspecify1tabletinsteadoftabletasthedose.Thepatientmust
clearlyunderstandwhathasbeendone,anditisbestpracticetonotifytheprescriber.
Aprescriptionwrittenforlevothyroxine225mcgperdosecannotbedispensedassuchbecauseno
manufacturermakesa225mcgtablet.Thepharmacistmaywishtoverifythedosetobesureanerrorwasnot
made,butotherwisehasthechoiceofdispensingtheprescriptionasfollows:
levothyroxine113mcg,withdirectionsof2tabletsperdose
or
levothyroxine200mcg,1tabletperdose,plus
levothyroxine25mcg,1tabletperdose,astwoseparateprescriptions
Ineithersituation,thebestpracticeistonotifytheprescriberwhatwasactuallydispensed.Also,ifthesecond
optionisused,eachcontainershouldbeexplicitthatthedoseshouldbetakenalongwiththedosefromthe
othercontainer,sothatthepatientunderstandsheorshemusttake2differentstrengthsoflevothyroxineto
achievethenecessarydose.
TABLETSPLITTINGPROGRAMS.Manyinsurersorthirdpartypayersencouragepatientstosplittabletstoachieve
costsavings.Forexample,Crestor10mgtabletswereavailableatonepointfromDrugStore.Comfor$474.39
for100tablets,whilethe20mgtabletswere$475.55for100,ornearlyhalfasexpensivepermg.Many
pharmacistsconsiderarequestbyapatienttoadjustthedoseontheprescriptiontobewithinthegeneral
reasonabledeviationfromtheprescriptiondiscussedhere.Notallpatientsaregoodcandidatesfortablet
splittingprograms,however.Becausetheprimaryinterestservedbytabletsplittingiscostsavings,notpatient
careissues,thepharmacistshouldprobablyproceedwithtabletsplittingprogramsonlywhenbasedonprior
consultationwithorapprovaloftheprescriber.
174
ITISIMPORTANTTHATTHEPRESCRIBERSRECORDSOFWHATISDISPENSEDARECONSISTENTWITHTHE
PHARMACISTSACTIONSTOAVOIDCONFUSIONANDPOSSIBLEOVERDOSE.Confusionoveratabletsplitting
programledtoafederallawsuitwhenapatientsufferedrhabdomyolysisafterhewasinstructedbyanurse
practitionertoincreasehissimvastatindoseto1wholetablet.Thenursepractitionerbelievedhewas
inappropriatelytakingonly20mgperday,wheninfacthewastakinghalfofan80mgtabletaspartofatablet
splittingprogram.
TRANSFERSOFPRESCRIPTIONSBETWEENPHARMACIES
Therearemanytimeswhenapatientrequeststhathisorherprescriptionbefilledatadifferentpharmacy,or
wishestotakeacopyoftheprescriptiontoanotherprescriberorpharmacy.
COPIES.Theoriginalofeveryprescriptionmustberetainedinthepharmacy.Sometimespatientswillrequest
acopyoftheirprescriptionforinformationalpurposes.Suchcopiesmaybemade,butmustbeclearlylabeled
assuch.(WAC246869100(e)).
Prescriptionsmaybephotocopiedandprovidedtothepatientorotherstowhomthepatienthasauthorized,
stampedwithCOPY.
Pharmacistsmayhandcopytheprescriptiononthepharmacysprescriptionform,indicatingaCOPY.
CODINGPRICESONCOPIESNOLONGERACCEPTABLE.Itwasthepracticeofpharmacistsinpastyearstoinclude
pricinginformationontheprescription,oftenincodedfashion.OnepopularcodewascalledtheNARDCode,
developedbytheNationalAssociationofRetailDruggists,nowknownasNCPA.Thiscodeusedtheword
PHARMOCISTwhereeachletterrepresentedthedigits,1234567890,respectively.ThelettersNA
precededthecodeanditwasfollowedbyRD.Forexample,NAPHMRDwouldindicateapriceof$1.25.This
practiceisuncommonnow,inpartbecauseofchallengestoitsuseasameansofpricefixingamong
competitors.
TheseCOPIESARENOTVALIDFORFILLING,sothepharmacistreceivingsuchacopymustcontacttheprescriber
andobtainaneworalprescription.
TRANSFEROFREFILLINFORMATION.PharmaciesareallowedunderWAC246869090totransferprescriptions,
alongwithavailablerefills,toanotherpharmacy.Itisimportantforthepharmacistorinterninvolvedinthe
processtofollowthestepslistedintheregulation.InWashington,pharmacistsorinternsmaytransferand
receivetransferredprescriptions.
THEORIGINATINGPHARMACIST(transferorpharmacist)mustperformthefollowingsteps:
Recordthattheprescriptionhasbeentransferredinthemedicationrecordsystem.
Recordinthemedicationrecordsystemthe
Nameandaddressofthepharmacytowhichithasbeentransferred
Thenameofthepharmacist(orintern)thatreceivedtheinformation.
Note:itisusagethatapersonsnameforlegalpurposesisthefullnamethatthepersonnormally
wouldusetoconductbusiness.Thus,simplyrecordingthefirstnameoftheotherpharmacistisnot
generallyappropriate.APharmacyCommissionconsultantpharmacisthasstatedthatNeitherWAC
246869norCFR1306.25definethewordnameasitisusedineachrespectivepassage.However,both
thelawandrulerequirebothtransferringpharmaciststobeidentifiedwhentransferringaprescription.
Thismay(ormaynot)beachievedbyrecordingthefirstnameonly.Theextentofrequiredinformation
175
WILLIAME.FASSETT
dependsonyourabilitytounequivocallyidentifytheotherpharmacistifrequiredtodosoatalater
time.290
Inaddition,forcontrolledsubstances(scheduleIII,IV,andV),theoriginatingpharmacistmustfollowthe
proceduresspecifiedin21CFR1306.25,whichincludethefollowing:
o Locatetheoriginalhardcopyofthetransferredprescription.
o WritethewordVOIDonthefaceoftheprescription
o Recordthename,address,andDEAnumberofthepharmacyreceivingtheinformationonthe
reverseoftheoriginalprescription,alongwiththenameofthepharmacistreceivingthe
information.
THERECEIVINGPHARMACISTtreatstheprescriptionasanoralprescription,andmustperformthefollowing
steps:
Reducetheprescriptiontowritingonaprescriptionblank,includingpatientname,address,prescribers
nameandaddress,andotherinformationrequiredtobeontheprescription.
WritethewordTRANSFERonthefaceoftheprescription.
Alsorecordthefollowing:
Thedatetheprescriptionwasoriginallywritten(cannotberefilledforayearafterthat.)
Whenprocessingatransferredprescription,itisimportanttooverridethecurrentdateinthecomputer,
andrecordtheoriginaldatewritten
Numberofrefillsremaining
Dateoflastrefill
Thenameandaddressofthetransferringpharmacy,andtheserialnumberoftheoriginalprescription
atthatpharmacy
Thenameofthetransferring(transferor)pharmacist.Asnotedabove,thisshouldnormallybethefull
legalnameoftheindividual.
Forcontrolledsubstances,thereceivingpharmacistmustalsorecordthefollowing:
o Numberoforiginalrefillsallowedontheprescription
o Dates(andlocations)ofallpreviousrefills
o Numberofvalidrefillsremaining
o DEAnumberoftransferringpharmacy
o Name,address,serialnumberandDEAnumberofpharmacyatwhichprescriptionwasoriginally
filled(ifdifferentfromtransferringpharmacy).
ForMEDICAREORMEDICAIDprescriptionsoriginallyissuedinwritingafterApril1,2008,thereceiving
pharmacistmust
Obtainandrecordfromthetransferringpharmacistverificationthattheoriginalprescription,ifa
writtenprescription,wasissuedonatamperresistantpad,orthatthetransferringpharmacyhad
obtainedverificationoftheprescriptionbyfax,phone,oremail.
MULTIPLETRANSFERS.Refillinformationandprescriptionsforlegenddrugsmaybetransferred,andre
transferredasoftenasneededuntilallrefillsareused.Ifapatienthashadaprescriptiontransferredtoanother
pharmacy,andnowwantstohaveitrefilledattheoriginalpharmacy,theoriginalpharmacymustcontactthe
otherpharmacyandreceivetheprescriptionbackasatransferredprescription.Atthispoint,itshouldbegivena
newprescriptionnumber.
176
AccordingtoDEArules,controlledsubstancesmaybetransferredonaonetimebasis,unlessthetransferring
pharmaciesshareacommonelectronicdatabase.(SeefurtherdiscussioninChapter5.)
Pharmacieswithacommonelectronicdatabasemaytrackrefillsfornoncontrolledsubstancesatanyoutletin
thiscommondatabase,withoutgoingthroughtheprescriptiontransferprocess.Manychains(e.g.,RiteAidand
Walgreens)havethesedatabases.
WAC246870030specificallyallowstransferofrefillinformationbetweenpharmaciesviafax.Theproposed
2015revisionofWAC246870retainsthisprovision.
MAYATECHNICIANTRANSFERREFILLINFORMATIONTOANOTHERPHARMACYVIAFAX?Justasanagentofthe
prescribercancommunicateinformationaboutaprescription,thereisnorulethatprohibitsthetechnician
completingthefaxtransmissionofrefillinformationtoanotherpharmacy,providedthatapharmacisthas
reviewedtheinformationonthefaxbeforethetechniciansendsit.Thefaxshouldbearthenameofthe
transferringpharmacist,andalsotheidentityofthetechnicianwhoiscommunicatingthatinformationonbehalf
oftheapprovingpharmacist.(Note:inSpring2014,PQACstaffindicatedtheydidnotbelievethattransferring
informationbyfaxmetthepharmacisttopharmacisttest.)
MAYAPHARMACISTTRANSFERANEWPRESCRIPTION?Itisnotclearthattherulesaswrittenpermittransfer
ofaprescriptionthathasnotbeenactuallyfilledatthetransferringpharmacy.However,itishardtoseewhy
thiswouldbemuchdifferentthantransferringinformationonanalreadyfilledprescription.Indeed,ifthe
originalprescriptionwasaverbalorelectronicprescription,thepharmacistcannotreallycreateawritten
prescriptiontohandtothepatient.Toconformwiththeletteroftherule,thetransferringpharmacyshould
entertheprescriptionintothepatientmedicationrecord,indicatethatitwasneverfilled,thenrecordthe
transferasindicatedabove,keepingtheoriginalprescriptiononfile.Alternatively,ifthepatienthaspresenteda
writtenprescription,thepharmacymaymerelyreferthepatienttoanotherpharmacy,andreturnthewritten
prescriptiontothepatienttotaketotheotherpharmacy,
PACKAGING
USPCONTAINERS.AlldrugsthatarerepackagedfordispensingtopatientsmustmeetUSPrequirements.
MultidosecontainersofsoliddosageformsmustmeetUSPrequirementsfortightcontainersthataresealed
tobeairandwaterresistant,andmustbeeitheropaqueorlightresistant.TheUSPalsoprovides
recommendationsformaterialsusedinunitdoseorBingoCardpackaging.
CHILDRESISTANTCONTAINERSREQUIREDFORPRESCRIPTIONDRUGS.Washingtonlaw
requiresthatthecapofeveryprescriptioncontainermeetsafetystandardsadoptedbythepharmacy
commission(RCW18.64.246).TheCommission,inturn,hasincorporatedbyreferenceChapter16,part1700of
theCFR(WAC246869230).Prescriptiondrugsareincludedamonghouseholdsubstancesthatmustbe
packagedinspecialpackagingasspecifiedinthePoisonPreventionPackagingAct(PPPA,15USC1471).These
containersarecommonlycalledChildResistantContainers(CRCs).ThePPPAisimplementedbyrules
promulgatedbytheConsumerProductsSafetyCommission(CPSC).TheCPSChaspublishedaguidefor
pharmacistsandotherhealthprofessionals.291
UNITOFUSEPACKAGINGFORRETAILPHARMACIES.Productspackagedbymanufacturersinunitofuseretail
units(e.g.,Zpacks,OTComeprazole20mg)areinpackagesthathavebeendesignedandtestedtomeetthe
requirementsforchildresistantcontainers.
177
WILLIAME.FASSETT
ALLPRESCRIPTIONSFORORALDOSAGEFORMSOFLEGENDDRUGSINWAMUSTBEDISPENSEDINCRCS,
EXCEPTFORDRUGPRODUCTSEXEMPTEDBYTHECPSC.Exemptedproductsarelistedin16CFR1700.14(a)
(10),andinclude:
Nitroglycerinesublingualtablets
Sublingualandchewableisosorbidetablets10mg PHARMACYCALCULATIONSINA
Erythromycinethylsuccinate,measuredas LAWTEXTBOOK!
erythromycinequivalent Exercise:howmanytabletsofChewable
o Granulesforsuspensionandsuspensions VitaminswithFluoridecontaining0.5mg
containing8g offluorideionpertabletmaybe
o Tabletscontaining16gperpackage dispensedinacontainerwithoutachild
Oralcontraceptivesinmemoryaidpackages resistantclosure?(Hint:1mgFis
Cholestyramineandcolestipolpowder containedin2.21mgofNaF.)
+
K supplements50mEq/doseinunitdosepackaging
NaF110mgperpackage(tabletsandliquids,mustbe0.5%elementalfluoridew/worw/v)
Oralcortisteroidtabletsinmanufacturersdispenserpackages(Dosepak,etc.)
o Prednisonecontaining105mgperpackage
o Betamethasonecontaining12.6mgperpackage
o Methylprednisolonecontaining84mgperpackage
Pancrelipasesoleingredientproducts
Mebendazoletablets600mgperpackage
Aerosolsforinhalation
Hormoneproducts
o Conjugatedestrogensinmnemonicpackagescontaining32mgperpackage
o Norethindroneacetateinmnemonicpackagescontaining50mgperpackage
o Medroxyprogesteroneacetatetablets
Sacrosidase(sucrase)inglycerolandwater.
HormoneReplacementTherapyProductsrelyingsolelyononeormoreestrogensorprogestogensfor
activity.
Colesevelamhydrochloridepowderinpackagescontaining3.75gperpackage
Sevelamercarbonatepowderinpackagescontaining2.4gperpackage
USEOFNONCRCCONTAINERS.PharmacistsmaydispenselegenddrugsinnonCRCsif:
THEPATIENTORTHEPATIENTSAGENTREQUESTS.Sucharequestmaybeablanketrequestthatall
drugsdispensedtothepatientbeinnonCRCs;or
THEPRESCRIBERREQUESTSITONTHEPRESCRIPTIONATTHETIMEITISWRITTEN.Prescribersmaynot
issueblanketrequests,eitherforalldrugsdispensedtoaparticularpatient,orforallofhisorher
patients.
REQUESTSFORNONCRCSMUSTBEINWRITINGINWASHINGTON.Underfederallaw,requestsfornonCRC
containersmaybeoralorinwriting.Washingtonincorporatesthefederalrulesintoitspharmacyregulations,
butrequiresinaddition,thatrequestsfornonCRCcontainersareINWRITING,bythepatientorthepatients
agent,orinwritingbytheprescriber.Authorizationbythepatientoragentshallbeverifiedinoneofthe
followingways:
Astatementonthebackoftheprescriptionsignedbythepatientoragent;
178
Astatementonthemedicationrecordrequestingnonchildresistantcontainers,or;
AsignedstatementonanyotherpermanentrecordrequestingnonCRCcontainers.(WAC246869
230(2))
Thedateoftherequestshouldbeincludedinthedocumentationkeptinthepharmacy.Atvarioustimes,
PharmacyCommissioninvestigatorshaveinsistedthatsuchrequestsberenewedaftersomereasonable
lengthoftime,suchasoneyear.Thisisagoodpractice,butitisNOTrequiredbycurrentWashingtonpharmacy
regulations.
NONCRCREQUESTSMUSTBEINPATIENTRECORD.AnindicationthatanonCRChasbeenrequestedmustbe
madeinthepatientmedicationrecordsystem.(WAC246875020(1)(j))
LEGALLIABILITYFORUSEOFNONCRCS.
IfapharmacistdispensesacovereddruginanonCRC,andachildisinjuredasaresultofgainingaccesstothe
drug,thechild,hisorherguardian,orthechildsestate(incasethechilddies),mayfilealawsuitagainstthe
pharmacistfordamages.InanIowacase292thepharmacistwasfoundliableforthedeathofachildwho
ingestedTedralSA(containingtheophylline)prescribedforherfatherthatwasdispensedinanonCRC.The
pharmacyarguedthatthefatherhadrequestedanonCRContheprescription,butdidnthaveawrittenrecord
tosubstantiatethis,andtheparentsclaimedotherwise.Normally,beingabletodocumentthattheparentor
guardianofthechildauthorizedtheuseofthenonCRCwillserveasadefenseagainstliability.However,most
childhoodpoisoningsfromlegenddrugsnowoccurasaresultofchildrenobtainingaccesstograndparents
drugs.Becausegrandparentsarenotnormallythelegalguardiansoftheirgrandchildren,theirrequestfornon
CRCsmaynotprovideanadequatedefense.Pharmacistsshouldconsiderincludingstatementscoveringthe
followingelementsintheformusedbypatientstorequestanonCRC.
1. CRCsarerequiredbylawunlessspecificallyrequestedotherwisebythepatient.
2. Thepurposeoftheseregulationsistopreventchildhoodpoisoningfromprescriptiondrugs.
3. Asfewasoneortwotabletsofsomedrugsmaybefataltoyoungchildren.
4. TheCPSChasreportedonestudywhichfoundthat36%ofchildhoodingestionsrelatedtoaprescription
vialinvolvedagrandparentsmedication.293
5. Over90%ofelderlypersonscansuccessfullyopenCRCsifshownhow.Thepharmacyiswillingto
providedemonstrationsandinstructionstothepatientonhowtoopenaCRC.Therearealternative
CRCsthatcanbeusedbypatientswitharthritisorlackofhandstrength,andthepharmacyiswillingto
obtainandprovidetheseatcosttothepatient.
6. Thepatientagreesthatitishisorherresponsibilitytokeepmedicationsoutofchildrensreach,
especiallywhenusinganonCRCcontainer.
7. Havingreadandunderstoodtheabove,thepatientneverthelessrequeststhatnonCRCsbeusedonhis
orherprescription,andagreestoindemnifyandholdharmlessthepharmacyforanyinjuriesthatmight
occurtoachildasaresultofthepatientsrequesttousenonCRCs.
Anexamplerequestformimplementingtheserecommendationsisprovidedattheendofthechapteras
Appendix4A.
FIXEDCONTAINERSIZEFORSUBLINGUALNITROGLYCERINE.Sublingualnitroglycerintablets(e.g.,
Nitrostat)arenowonlyavailablefordispensinginbottlesof25tablets,topreservestability.FDArulesindicate
thattheseproductsmaynotberepackaged,sopharmacistsshouldnotundertaketodoso.
179
WILLIAME.FASSETT
MEDISETSANDCOMPLIANCEPACKAGING.Medisets,pharmacypackagedblistercards(Bingo
Cards),andsimilarpackageshavenotmetfederalstandardsforCRCs,thus,pharmacistsmustobtainrequests
fromthepatientstousenonCRCpackaging.
PHARMACISTADMINISTRATIONOFDRUGSTOPATIENTS
ISCERTIFICATIONREQUIREDTOADMINISTERDRUGS?No.Pharmacistsmayadministerdrugs
orderedforapatientbyanauthorizedprescriber,byanyroute,byvirtueoftheirlicensetopractice.
CertificationprogramsforimmunizationsarepartoftheprocessbywhichpharmacistsinWashingtonmayeasily
gaindocumentedcompetenceandadheretothetermsofaprescriptiveauthorityprotocoldevelopedbyWSPA
andendorsedbytheCommissioninordertoprescribevaccines.However,apharmacistmaydevelopa
prescriptiveauthorityprotocoltoprescribeandinjectdrugswithoutcertification,aslongasanauthorized
prescriberagreestotheprotocol.Clearly,pharmacistsshouldnotundertakeproceduresunlesstheyare
adequatelyskilledinthem.
Notethatsome3rdpartypayers(e.g.,Medicaid)willnotreimbursepharmacistsforadministrationofvaccines
unlesstheyhaveacollaborativepracticeagreementonfilewiththeCommission(seeChapter8).
AVOIDPREFILLINGVACCINESYRINGES.ThePharmacyCommissionhasalertedpharmacistsinvolved
influshotclinicsthattheCentersforDiseaseControlstronglyrecommendsthatprovidersdonotprefill
individualsyringesbecauseofrisksofadministrationanddosingerrorsandconcernsoverstability.294
MERCURYCONTAININGVACCINESANDINJECTIONS.Washingtonlawprohibitsinjectionofa
vaccine(orotherproduct)containinggreaterthan0.5mcgofmercury(presentinthimerosol)per0.5mLdose
intoapersonKNOWNTOBEPREGNANToraCHILDUNDER3YEARSofage.(RCW70.95M.115).
EXCEPTIONFORFLUVACCINES.Influenzavaccines(seasonalandH1N1)maycontainupto1mcgofmercuryper
0.5mLdose.
EXCEPTIONFOREMERGENCY.ThesecretaryoftheDOHmaysuspendtheserestrictionsupondeclarationofa
publichealthemergency(i.e.,anoutbreakorvaccineshortage),forthedurationoftheemergency.Awoman
knowntobepregnantorlactating,andtheparentorguardianofanyminorwhobevaccinatedwithaproduct
containingmercuryabovethelimits,mustbeinformedofthefact.
ADMINISTRATIONOFDRUGSTOPATIENTSBYOTHERPERSONS
OTHERHEALTHPROFESSIONALSWHOMAYADMINISTERDRUGS
Anyonewhomayprescribedrugsmayadministerdrugs.
NURSES,BOTHRNSANDLPNS
STUDENTNURSES,whenpartoftheiracademicprogramunderfacultyoversight(unlikestudent
pharmacists,studentnursesarenotindividuallyregistered,exceptwhentheyareemployedasnursing
technicians)
NURSINGTECHNICIANS,underdirectsupervisionofnurseanursingtechnicianisastudentnursewho
isemployedbyahospitaloutsideofhisorheracademicprogram.MAYNOTADMINISTER
180
chemotherapy,bloodorbloodproducts,IVmeds,scheduleddrugs,orcarryoutproceduresoncentral
lines
RESPIRATORYCAREPRACTITIONERSmayadministerprescribedororderedrespiratorydrugs
MEDICALASSISTANTS.FourtypeofmedicalassistantsarecredentialedbytheDepartmentofHealth:
MEDICALASSISTANTCERTIFIED.Mayadministermedicationsiftheyare
Administeredbyunitorsingledosage,orbyadosecalculatedandverifiedbyapractitioner
Limitedtolegenddrugs,vaccines,orscheduleIIIVcontrolledsubstancesauthorizedbyapractitionerin
accordancewithDOHrules
Maynotbeexperimentaldrugsorchemotherapyagents.
DOHmaybyrulefurtherlimitallowabledrugs
Administeredpursuanttoawrittenorderbyapractitioner
Mayadministerintravenousdiagnosticagentsordrugsasdelegatedandsupervisedbypractitioner,
subjecttoqualificationsestablishedbyDOHrule
DOHrulesprohibitMACsfromadministering
o ScheduleIIcontrolledsubstances,chemotherapyagents,orexperimentaldrugs
o Medicationsthroughacentralvenousline
TheMACmaynotstartanIVline,butmayinterruptanIVline,administeraninjection,andrestartat
thesamerate.
Allowedcategoriesofdrugsaresetforthinatableintheregulation(WAC2468270240(5):
MEDICALASSISTANTHEMODIALYSISTECHNICIAN.
Mayadministerdrugsandoxygentoapatientwhendelegatedandsupervisedbyapractitioner,subjecttoDOH
rules.
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WILLIAME.FASSETT
MEDICALASSISTANTPHLEBOTOMIST.Noauthoritytoadministerdrugs.
MEDICALASSISTANTREGISTERED.
Extentofactivitiesandproceduresmustbesetforthbysupervisingpractitioner.AnMARcannottransferhisor
herauthorizeddutiestoanothersettingwithoutauthorizationfromthenewpractitioner
Underthedelegationandsupervisionofapractitioner,mayadministereyedrops,topicalointments,and
vaccines,includingcombinationormultidosevaccines.
LICENSEDMIDWIVES(maybedesignatedC.P.M.forCertifiedProfessionalMidwife)maypurchaseand
administerprophylacticophthalmics,postpartumoxytocics,vitaminK,Rhoimmuneglobulin,andlocal
anesthetics;pharmacistsdispensingsuchdrugstoamidwifearenotliableforanyadversereactionscausedby
anymethodorusebythemidwife.(RCW18.50.115)Inadditiontothestatutorymedications,midwivesmay
administercertainIVfluids(LR,D5LR,heparin,NS),intradermalsterilewater,magnesiumsulfate,epinephrine,
MMRvaccine,HBIGorHBV,terbutaline,antibioticsforintrapartumprophylaxis,antihemorrhagicpostpartum
drugs(misoprostol,methylergonovinemaleate,PGF2alpha.(WAC246834250)
OCCUPATIONALTHERAPISTSANDPHYSICALTHERAPISTSmaypurchase,use,andadministermodalitiesand
certainotherdrugsusedinphysicaltherapy.
DENTALHYGIENISTSmayadministerlocalanesthetics,topicalantimicrobials,andtopicalfluoridesfordental
patients
EMERGENCYMEDICALSYSTEMPERSONNEL.Thestatelicensesorcertifies4categoriesofEMSpersonnel:
ADVANCEDEMERGENCYMEDICALTECHNICIANS(AEMTS)certifiedasanintermediatelifesupport
technicianasdefinedinRCW18.71.200,whichincludesadvancedcardiacandtraumalifesupport.
EMERGENCYMEDICALRESPONDER(EMR)certifiedasafirstrespondertoprovideprehospitalEMScare
(ambulanceattendants)
EMERGENCYMEDICALTECHNICIAN(EMT)certifiedtorenderprehospitalEMScareaccordingtorules
setbyDOH
PARAMEDICaphysicianstrainedemergencymedicalserviceparamedicwhoistrainedtoperform
allphasesofprehospitalemergencymedicalcare,includingadvancedlifesupport,underwrittenororal
authorizationofMedicalProgramDirectororaphysiciandesignate.
Ingeneral,thescopeofpracticeoftheseindividualsisspecifiedbytheMedicalProgramDirector(MPD)ofthe
countyEmergencyMedicalServicesdepartment.EMTs,AEMTs,andParamedicsmayadministerprescribed
drugswithintheprotocolsestablishedbytheMPDperverbalorwrittenordersofaMDorDOcredentialedby
theMPD.
PROVISIONOFDRUGSBYHOSPITALPHARMACIESTOAMBULANCEORAIDSERVICES.Hospitalpharmaciesmay
providedrugstoambulanceoraidserviceslicensedunderRCW18.73.130foruseassociatedwithproviding
emergencymedicalservices,when:
Thehospitalislocatedinthesameoranadjacentcountyastheambulanceservice;
Amedicalprogramdirectoroftheambulanceoraidservicehasrequesteddrugsfromthehospitalper
anagreedprotocol;
Drugsrequestedmustbe(a)relevanttothelevelofserviceprovidedandthetrainingofitsemergency
personnel;and(b)areapprovedaspartofprehospitalpatientcareprotocolsapprovedforuseby
emergencypersonnelinthecountyinwhichtheambulanceoraidserviceislocated
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Theprovisionofdrugsbythehospitalpharmacyisnotcontingentuponarrangementsfortransportof
patientstothehospitalforreasonsotherthantheconsiderationofpatientsmedicalneeds(RCW
18.64.540)
RADIOLOGICALASSISTIVEPERSONNEL
RADIOLOGICTECHNOLOGISTSmayadministerdiagnosticandtherapeuticagentsunderthedirectsupervision
ofaphysician.
RADIOLOGISTASSISTANTSmayadministerimagingandnonimagingagentsparenterally,administerprescribed
oxygen,andadministeroralmedications.Oralmedicationsandparenteraladministrationrequiredirect
supervisionbyaphysician.
NONHEALTHCAREPROFESSIONALSWHOMAYADMINISTERDRUGS
SCHOOLPERSONNELincludingtrainedparaeducatorsmayadministerdrugstostudentsinaccordancewith
schooldistrictpoliciesandstateregulations.295
Statesthatgivetrainedschoolpersonnelauthoritytoadministerepinephrinehavepreferenceregardingcertain
federalasthmagrants.296
NONPRACTITIONERJAILPERSONNELmayprovidemedicationassistancetoinmatesandadministerdrugsvia
oralrouteorinhalation.(SeeChapter3,CorrectionalFacilities)
SHIPCAPTAINSONOCEANGOINGVESSELS,whenahealthcarepractitionerisnotstationedontheship(e.g.,
largefishingvessels),maystockandadministerdrugsincaseofemergencies.
ENTITIESAUTHORIZEDTOSTOREANDUSEEPINEPHRINEAUTOINJECTORS.Organizationsorentitieswhere
allergenscapableofcausinganaphylaxismaybepresentmayobtain,store,andadministerepinephrine
autoinjectors.Suchentitiesinclude,butarenotlimitedto,restaurants,recreationcamps,youthsportsleagues,
amusementparks,colleges,universities,andsportsarenas,inaccordancewiththeprovisionofRCW
70.54.440:297
Authorizedhealthcareprovidersmyprescribeepinephrineautoinjectors(EAs)inthenameofan
authorizedentity.
Pharmacists,ARNPs,orphysiciansmaydispenseEAspursuanttosuchprescriptions.
Anauthorizedentitymust
o StoreEAsinalocationreadilyaccessibleduringanemergencyinaccordancewiththeEAs
labelingandanyregulationspromulgatedbytheDOH
o Designateemployeesoragentstoberesponsibleforstorage,maintenance,andgeneral
oversightofEAsacquiredbytheentity
o Designatedemployeesmusthaveundergonetrainingspecifiedinthestatute(RCW
70.54.440(4))
o SubmitareporttotheDOHofeachincidentinwhichEAsareused
Designatedtrainedagentsoremployeesmay
o ProvideanEAtoanyindividualbelievedtobeexperiencinganaphylaxisforimmediateself
administration,oradministeranEAtosuchanindividual,regardlessofwhethertheindividual
hasbeendiagnosedwithanallergyorhasaprescriptionforanEA
Thestatutelimitsliabilitiesofauthorizedentitiesanddelegatedagentsforinjuriesresultingfrom
administrationorselfadministrationofEAsingoodfaithincompliancewiththestatute.
AdministrationofanEAincompliancewiththestatuteisnot"thepracticeofmedicine."
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WILLIAME.FASSETT
DELIVERYOFDRUGSTOPATIENTS,CAREGIVERS,ORPRESCRIBERS.
Ingeneral,pharmacieshavetraditionallyacquiescedtorequestsfrompatientstodelivertheirprescriptionsto
theiroffice,theirhome,theirphysician,orsomeotherplaceconvenientforthepatient.However,avarietyof
federalandstatelawsandrulescreatelimitationsonhow,andwhere,andtowhom,apharmacistmaydelivera
patientsprescription.
Alsoingeneral,thepharmacymayusepharmacyemployees(registeredatleastaspharmacyassistants)to
deliverdrugstopatients,ormayusecommoncarriers(FedEx,UPS,etc.),orspecialcarrierssuchascouriersor
taxicabs,ortheUnitedStatesPostalService,todeliverdrugs.Volunteersaremoreproblematic,andmayor
maynotbeuseddependingonspecialcircumstances.Otherhealthprofessionalswhoarenotemployeesofthe
pharmacyarevolunteers.Whenevernonpharmacypersonnelareutilized,caremustbetakentopreservethe
securityandstabilityofthedrugs,andtopackagethedruginsuchawayastoavoiddisclosingprotectedhealth
information.
PHARMACYCOMMISSIONRULESforcommunitypharmaciesindicatethattheprescriptionmaynot
leavethepharmacyunlessitisdelivereddirectlytothepatient,anagentofthepatient,orthepatientshome
orsimilarplace.(WAC246869020(5))ThisappearstoapplytoNONCOMPOUNDEDPRESCRIPTIONSFOR
LEGENDDRUGS.
CONTROLLEDSUBSTANCES.ThefederalCSAandWashingtonsparallelstatute,however,restrictdelivery
ofcontrolledsubstancesunlesstheyaredirectlydeliveredtotheULTIMATEUSER.Theultimateuseristhe
patient,oramemberofthepatientshousehold.(21U.S.C.802(27))Thistechnicallypreventsapharmacist
fromdeliveringacontrolledsubstancetoarelativeofthepatientwhodoesnotlivewiththepatient.TheDEAs
PharmacistManualdoescontemplatedeliveringtothepatientviacommoncarrier,ortheUSPostalService.
(SeeChapter5)
COMPOUNDEDPRESCRIPTIONS.ThePharmacyPracticeActallowscompoundedprescriptionstobe
deliveredtolocationsotherthanapatientshomewhenrequestedbythepatient;ortheprescribertobe
administeredtothepatient;ortoanotherpharmacytodispensetothepatient.(RCW18.64.011(15)(d))
GiventhepotentialconflictbetweenthePharmacyCommissionruleandthePharmacyPracticeAct,itcanbe
expectedthattheCommissionwillharmonizeitsrulewiththeAct.However,theDEAhasbeenfairlystrictin
applyingitsregulationstopharmacies,andhastreateddeliveryofcontrolledsubstancestotheprescribing
physicianforlaterdeliverytothepatientasaviolation.(SeeChapter5)
RETURNOREXCHANGEOFDRUGSFROMCONSUMERS.
Generally,PHARMACIESMAYNOTACCEPTRETURNSOREXCHANGESOFDRUGS,itemsof
personalhygiene,orsickroomsupplies,aftertheitemshaveleftthepharmacy.(WAC246869130)(TheFDA
issuedacompliancepolicyguidein1980inwhichitstatedthatapharmacistshouldnotreturndrugproducts
tohisstockoncetheyhavebeenoutofhispossession.Thepharmacistordoctordispensingadrugislegally
responsibleforallhazardsofcontaminationoradulterationthatmayarise,shouldhemixreturnedportionsof
drugstohisshelfstocks.298)Controlledsubstancesmaybereturnedtopharmaciesfordestructiononlyin
accordancewithDEArules.
184
Whileconsumersmaynotreturndrugstoapharmacist,theymaydisposeofdrugsbytakingthemtoasecure
disposalsite,whichmayincludeadisposalboxlocatedatapharmacythatcomplieswithDEArulesfordisposal
ofcontrolledsubstances(21CFRPart1317seealsoChapter5).TheCommissionhaspublishedaguidance
documentinterpretingtheDEArulesandtoprovidestepsbywhichretailpharmacies,hospitalsandclinicswith
onsitepharmacies,andanyLTCfacilitiesthatthepharmacieschoosetoregisterascollectionsiteswiththe
DEA.299
UNITDOSEPACKAGINGEXCEPTION.Unitdosepackagesorfullorpartialmultipledosemedication
cardsmaybeacceptedfromhospitalsorlongtermcarefacilities,if
thepharmacistcandeterminethatthepackageisintact;
thepharmacistdeterminesthattheunitdosepackageoramultipledosemedicationcardmeetsUSP
standardsforstorageincludingtemperature,lightsensitivitychemicalandphysicalstability;
thedrughasbeenstoredinsuchamannerastopreventcontaminationbymeansthatwouldaffectthe
efficacyorandtoxicityofthedrug;
thepharmacistknowsthatthedrughasalwaysbeenunderthecontrolofathirdpartytrainedand
knowledgeableinthestorageandadministrationofdrugs;
thelabelingorpackaginghasnotbeenalteredordefacedsothattheidentityofthedrug,itispotency,
lotnumber,andexpirationdateisretrievable;and,
ifthedrughadbeenprepackaged,itwasnotmixedwithdrugsofdifferentlotnumbersand/or
expirationdates,unlessthespecificlotnumberswereretrievableandexpirationdatesaccompanythe
drug.Ifthedrugisextemporaneouslypackaged,itshallnotbemixedwithdrugsofdifferentexpiration
datesunlesstheearliestexpirationdateappearsonthelabel.
DURABLEMEDICALEQUIPMENT,includingmobilityaidsandwheelchairs,whichmaybecleanedand
sanitized,maygenerallybereturned.
Seealsothesectionondisposalofdrugs,below.
RECALLS
TheFDAmayseizeactualpackagesofdrugsthatareadulteratedormisbranded.Toprecludeseizure,
manufacturersmayvoluntarilyrecalladulteratedormisbrandeddrugs.(Note:theFDAmayinitiatearecallof
noncomplyinginfantformulasorformedicaldevices.)
RECALLEDDRUGSCANNOTBEDISPENSED.Anydrugforwhicharecallisannouncedmustbeassumed
tobeeithermisbrandedoradulterated,andthusmaynotbesoldordispensedwithoutviolatingtheFDCA.
Dispensingarecalleddrughasledtocivillawsuitswhenthepatientwasinjuredbythecontinueduseofthe
recalleddrug.300
LEVELSOFRECALLS.Recallsmayextendtooneofthefollowinglevels(inincreasingorderofseverity):
WHOLESALERLEVELonlyproductsintheinventoryofawholesaledistributorneedtobereturnedto
themanufacturer.
RETAILLEVELonlyproductsstillintheinventoryofapharmacy(orawholesaler)mustbereturnedto
themanufacturer.
CONSUMERLEVELMOSTSERIOUSINADDITIONTOWHOLESALERSANDPHARMACIES,CONSUMERS
AREINSTRUCTEDTORETURNOFFENDINGPRODUCTSTOTHEMANUFACTURER
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WILLIAME.FASSETT
CLASSESOFRECALLS.WhentheFDAapprovesavoluntaryrecall,itdeterminesandpublishesa
classificationoftherecalltoindicateitsseverity.
CLASSIMOSTSERIOUStherelikelihoodofinjuryordeathfromtheuseoftheproduct;mayincludeapublic
warning.Themanufacturermay,initsrecallnotice,requestretaildistributorstonotifyconsumersoftherecall.
THEFDASCOMPLIANCEPOLICYGUIDEONCLASSIRECALLSOFDRUGS301requiresthatpharmacies,hospitalsand
nursinghomepharmacistsreviewtheirprescriptionfilestodeterminewhichpatientsmayhavereceivedthe
specificlotnumbersinvolvedinanyClassIrecall,andmustthennotifythepatientsphysiciansofthespecific
problem,andkeeparecordofthenotification.Ifthepharmacycannotseparateoutlotnumberstoidentify
patientswhoreceivedthespecificproductinvolvedintherecall,theymustnotifythephysiciansofallcustomers
whoreceivedthedrug.TheFDAwillalsoundermostcircumstancesissueawarningtothegeneralpublic.
Comment:Icanfindnorecordofanypharmacybeingsubjecttodisciplineorprosecutionforfailingtocomplywiththis
guidance.However,pharmacieshavebeensuedincivilcases,allegingthatthenotificationwasnotmadeorwasmadetoo
lateduringthe2008recallofDigitek.302
THEJOINTCOMMISSIONrequiresaccreditedinstitutionstoadheretoPolicyMM.4.70regardingmedication
management,whichstates,ThepharmacymustretrievemedicationsrecalledordiscontinuedbytheFoodand
DrugAdministration(FDA)orthemanufacturer.
StaffretrievemedicationsaccordingtotheorganizationspolicywhentheFDAorthemanufacturer
informsthehospitaloftherecall.
Thehospitalmustnotifyallstaffordering,dispensing,andgivingoutmedicationswhentheFDAissuesa
recallorder.
Staffidentifyandnotifypatientswhomayhavereceivedtherecalledmedication.303
CLASSIIhealthproblems,ifany,areexpectedtobetemporaryorreversible
CLASSIIIuseoftheproductisNOTlikelytocausehealthproblems
MARKETWITHDRAWALminorhealthriskorminorFDAviolation
SAFETYWARNINGSANDLABELREVISIONSFROMFDA
WHATSHOULDPHARMACISTSDOWHENTHEFDAISSUESSAFETYALERTSORREVISED
DOSAGEGUIDELINES?BecausetheFDAhasauthoritytoforcemanufacturerstomakelabelrevisionsasa
resultofsafetyconcerns,thebestapproachtodealingwithannouncements,suchastherecentreduceddosage
limitsforzolpidem304andcitalopram,305istoconsiderthemasatypeofrecalloftheapprovedlabeling.Once
theFDAhaspublicizedthroughaDrugSafetyCommunicationasignificantrevisionofthemaximumdosageof
aproduct,forexample,thiswouldseemtotriggerthepharmacistsidentificationofpossibleclinicalmisuseof
thedrug,and,attheveryleast,wouldrequirecontactingtheprescribertodiscusstherevisionswhenanew
prescriptionorrequestforrefillisforadosethatexceedsthenewmaximums.Itiseasyforeverypharmacistto
learnoftheseDrugSafetyCommunicationsbysubscribingtoMedWatch.306
ArecentlawsuitinWashingtonarosewhenahealthcaresystemtookseveralmonthstoissuewarningsdirectly
topatientsaboutthereviseddosingofcitalopram,andtheestateofadeceasedpatientallegedthatherdeath
186
resultedfromfailuretopromptlyreducehercitalopramdose.Thecasesettledwithoutthehealthsystem
admittinganyliability.
DRUGSHORTAGES
Inrecentyears,theUSdrugsupplychainhasexperiencedaspateofdrugshortages,particularlycriticaldrugs
usedininstitutionalpractice.AccordingtotheFDA,therewere178drugshortagesreportedin2010(132were
forinjectabledrugs),and251shortages(183injectables)reportedin2011.307TheFDAmaintainsawebsiteon
drugshortages308andtheAmericanSocietyofHealthsystemPharmacistsoperatesadrugshortageresource
center.309Anticipatingshortagesandassistingotherprovidersandpatientsindealingwithshortagesofcritical
drugsarebecomingimportantprofessionalresponsibilitiesforpharmacists,particularlyinhospitals.
CongressgaveFDAadditionalpowertomanagedrugshortagesandtrackshortagesandthreatenedshortagesin
its2012enactmentofFDASIA.310By2015,thenumberofshortagesreportedbyFDAhaddeclinedto41.
MANUFACTURERSMUSTREPORTDISRUPTIONS.ManufacturersofalldrugsthatareLIFE
SUPPORTING,LIFESUSTAINING,orareINTENDEDFORUSEINTHEPREVENTIONOFADEBILITATINGDISEASEOR
CONDITION,INCLUDINGANYSUCHDRUGUSEDINEMERGENCYMEDICALCAREORDURINGSURGERY,must
notifyFDAofpermanentdiscontinuanceofthedrugorofaninterruptioninthemanufactureofthedrugthatis
likelytoleadtoameaningfuldisruptioninsupply,andthereasonsforthediscontinuationorinterruption.
Noticesmustbemade6monthspriortothedateofdiscontinuanceordisruption,orassoonaspracticable
FDAmustnotifyappropriateorganizationsofdiscontinuationsorinterruptions,andmustprovideameansfor
organizationsorproviderstonotifyFDAofshortages
AnoticeofacontrolledsubstancedisruptionorshortagemaygeneratearequestfromFDAtoDEAtoalter
productionquotasasnecessarytohelpovercomeshortages.TheAttorneyGeneralmustprovidereasonsfor
rejectingtherequest,whichmustbemadepublic.
Pharmacistsmustworktoassure,particularlyininstitutionalsettings,thatanimpendingdrugshortagetriggers
carefulassessmentandplanningtominimizetheimpactoftheshortageonpatients,andtoassurethat
alternativedrugs,packages,anddosageformsareutilizedinsuchamannerastoavoidpatientsafetyrisks.311
Federalandstatestatutesenactedin2013provideforcompoundingofdrugssubjecttoshortagesby
outsourcingfacilitiesand/orcompoundingpharmacies.(SeesectiononCompounding).
DISPOSALOFOUTDATEDDRUGSOROTHERDANGEROUSWASTE
Pharmaceuticalwasteshavebeenregulatedformanyyears,butrecentpublicityinthenationalpressin2008
hasincreasedattentionontheissue.TheAssociatedPressreportedinMarch2008thatdrugshadbeen
detectedinthedrinkingwatersuppliesof24majormetropolitanareas.InSeptember,theAPreportedthatan
EPAsurveyrevealedthatthemajorityof5,700hospitalsand45,000longtermcarefacilitiesflushunwanted
drugsdownthedrainanddonotdocumentamounts.Datafrom14facilitiesinMinnesotaextrapolatestoover
250millionpoundsofdrugwasteannually,includingpackaging.Congressionalhearingswereheldin2008as
well.
WASTEMANAGEMENTCOMPANIES.Understateandfederallaws,eachnonhouseholdwaste
generator(suchasapharmacy,clinic,orhospital)isrequiredtohandleitswastetoassurethatdangerousand
hazardouswastesaredisposedappropriately.Severalnationalcompaniesnowprovideasuiteofprograms
combiningreversedistributionwithwastemanagementtohelppharmaciescomplywiththelaw.Some,like
187
WILLIAME.FASSETT
WasteManagement,primarilyhandlenonviablepharmaceuticalwaste.Othersareprimarilyreverse
distributors,suchasGuaranteedReturnsandNationalPharmaceuticalReturns,andsome,likeStericycle,offer
bothwastemanagementandreversedistribution.
WASTECATEGORIES.Thefourmajorcategoriesofwasteareliquid,gaseous,radioactive,andsolidwaste.
Wastemaybehazardousornonhazardous.Mostpharmacies(otherthannuclearpharmacies)produce
primarilyliquidandsolidwaste,andmostpharmaceuticalwasteisaformofsolidwaste.
WASTESTREAMS.Atonetime,pharmaciesdumpedalltheirwasteinasingletrashreceptacle,whichwas
thenpickedupbythegarbagecollectorandmostcommonlytruckedtoalandfill(ordump).Theoperationsofa
pharmacycreate,however,severaldistinctstreamsofunwantedmaterials.Eachfacilitymusthaveaplanand
processfordealingwitheachofthesestreams,andmusttrainstafftohandlewastesafelyandappropriately.
Protectionsforindividualworkershandlingdangerousorhazardousproductsandmaterialsaresubjectto
regulationsissuedbytheOccupationalSafetyandHealthAdministration(OSHA)oritsstatecounterpart(WISHA
inWashington).
RETURNABLEPRODUCTS.Dependingonthenatureofthesalescontractbetweenthepharmacyandits
suppliers,unsold,overstocked,defective,recalled,oroutdatedproductsmaybereturnedforcredit.Inmany
instances,theseproductscannotberesoldorreused,andthemanufacturerwillneedtodeterminehowto
disposeofthem.MostpharmaciesnowutilizetheservicesofREVERSEDISTRIBUTORSwhocollectreturnable
products,separatethembymanufacturer,obtainavailablecredits,andreturncreditpaymentstothepharmacy,
lesstheservicefee.Reversedistributorswhohandlereturnsofcontrolledsubstancesmustberegisteredwith
theDEA,andthesefirmscanhandlecontrolledsubstancesthatareintendedfordestruction.
RECYCLABLES.Asignificantportionofthewastegeneratedbypharmaciescanberecycled.Paperpackaging,
cardboard,paperrecords,labels,glassandmetalpackages,batteries,electriclightingelements,andmanyother
itemsneedtobeseparatedintoarecyclingstreamatthesourceinmostmunicipalities.
MEDICALBIOHAZARDWASTEneedstobesegregatedandstoredtoavoidhumanexposurepriortoits
destruction,andmostofitisultimatelyincinerated.Sharpsdisposalisapartofmedicalwastemanagement.
DANGEROUSANDHAZARDOUSSOLIDWASTEproducedbypharmaciesdiffersfrombiohazardwasteinthatit
consistsprimarilyofchemicalcompoundsthatmustbekeptoutofairandwater.
NONHAZARDOUSSOLIDWASTETHATCANNOTBEREADILYRECYCLEDincludesfooditemsandmaterialsfor
whicharecyclingmarketdoesntcurrentlyexist.
FEDERALREGULATIONOFPHARMACEUTICALWASTEisgovernedbytheResourceConservation
andRecoveryActof1976(RCRA),312theprincipalfederalstatutedealingwithsolidwastedisposal.Thestatuteis
enforcedbytheEnvironmentalProtectionAgency(EPA),withregulationsin40C.F.R.parts238282.Congress
amendedtheRCRAbytheHazardousandSolidWastesAmendmentsof1984,313whichaddedsmallquantity
generators(e.g.,pharmacies)andestablishedrequirementsforhazardouswasteincinerators.ThefederalClean
WaterAct(CWA)314alsohasimplicationsforpharmaceuticalwaste,becauseitsetsgoalsforeliminationoftoxic
substancesfromdrinkingwater.TheCWAisalsoenforcedbytheEPA.
LISTEDCHEMICALS.TheEPAcurrentlymaintainslistsofspecificchemicalsubstances,someofwhichare
pharmaceuticals.InparticulartherearePlistedandUlistedchemicals.
188
EXAMPLEPLISTPHARMACEUTICALS
ArsenictrioxideP012
EpinephrinebaseP042(saltsexemptedfederally,butnotinWA)
NicotineP075
Phentermine(C4)P046
PhysostigmineP204
PhysostigminesalicylateP188
Warfarin>0.3%P001
EXAMPLEULISTPHARMACEUTICALS
Chloralhydrate(C4)U034
ChlorambucilU035
CyclophosphamideU058
Daunomycin(daunorubicin)U059
MelphalanU150
LindaneU129
Warfarin<0.3%U248
CONTAINERSthathaveheldlistedchemicalsaretreatedashazardouswaste.Plistcontainersarenotconsidered
emptyunlesstheyhavebeentriplewashedandthewashingsolutiontreatedashazardouswaste.Ulist
containersareconsideredemptyifallcontentsareremovedthatcanberemovedthroughnormalmeans,and
nomorethan3%byweightremains.
CHARACTERISTICSOFHAZARDOUSNESS.Awasteishazardousifithasoneormoreofthefollowing
characteristics
IGNITABLILITY
Solutionswithflashpoints<140F
o Aqueouswith>24%alcohol
o Nonaqueous
Oxidizers
Flammableaerosols
RubbingAlcohol
Topicalpreparations(e.g.,clindamycinphosphatetopicalsolution)
Injections(e.g.,paclitaxelinjection)
CORROSIVITYAqueoussolutionwithpH2or12.5
Glacialaceticacid
Sodiumhydroxide
TOXICITY40chemicalsincludedinPorUlists
HEAVYMETALSselenium,chromium,andsilver
Seleniuminjection
Chromiuminjection
Silversulfadiazinecream
PRESERVATIVESthimerosolandmcresol
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WILLIAME.FASSETT
Influenzavaccines
Insulininjections
REACTIVITYexplosiveandwaterreactivewastes.Nitroglycerinformulationsareexcludedfederallyandinmost
statesunlesstheyexhibitignitability
CHEMOTHERAPYAGENTSarenotfullyregulatedbyEPA.About100agentsarenotfederallyregulatedunderthe
RCRA,butmostarestateregulated.Chemotherapywastesthatareregulatedfallintothreecategories:
TRACEWASTE(YELLOWLABEL/CONTAINER),includingemptyvials,syringes,ivs,gowns,gloves,ziplock
bags.Thesearetreatedasinfectiousmedicalwasteandincineratedasmedicalwaste.
BULKCHEMOWASTE(BLACKCONTAINER)ifnotempty,shouldbeplacedintoRCRAhazardouswaste
container
SPILLCLEANUP(BLACKCONTAINER)managedasRCRAhazardouswaste
UNIVERSALWASTE.UniversalwasteisageneralcategoryofRCRAwastethatallowscombiningintoasingle
wastestream.PlistedandUlistedwastemustbedesignated(segregatedandlabeledseparately)bythe
wastedesignator,whereasuniversalwastedoesnot.TheEPApublishedaproposedrulethatwouldplace
pharmaceuticalwastegeneratedbyhealthcareentitiesintotheUniversalWastecategory.315,Basedon
commentsreceived,theagencywithdrewtheproposalandhasissuedarevisedproposalin2015.316The
revisedrulewillfocusonwastesgeneratedbyhealthcarefacilities.
2017EPAWasteGeneratorRule.TheEPAadministratorsignedafinalruleinNovember2016thatalters
definitionsofhazardouswastegeneratorsandallowsflexibility,includingreducingtheburdenonverysmall
quantitygenerators.TherulegoesintoeffectonMay30,2017.317
TheEPAmaintainsaHazardousPharmaceuticalsWikithatpharmacistsandotherhealthprofessionalsmay
accesstohelpthemcomplywithfederalrulesandtolearnaboutrequirementsintheirownstates
(hwpharms.wikispaces.com).
WASHINGTONSTATEREGULATIONOFPHARMACEUTICALWASTE.TheDepartmentofEcology
regulatesdisposalofdangerouswastes.Solidwaste(suchasdrugsormedicaldevices)maybedesignatedas
dangerous,andifso,itmustbedisposedofinaccordancewiththeDepartmentsregulationsand/orfederal
regulations.TheDepartmenthasestablisheda4stepprocessbywhichawastegeneratorcandetermineifa
solidwasteisdesignatedasaDANGEROUSWASTE:
(a)Todeterminewhetherornotasolidwasteisdesignatedasadangerouswasteapersonmust:

(i)First,determineifthewasteisalisteddiscardedchemicalproduct,WAC173303081;

(ii)Second,determineifthewasteisalisteddangerouswastesource,WAC173303082;

(iii)Third,ifthewasteisnotlistedinWAC173303081or173303082,orforthepurposesofcompliancewith
thefederallanddisposalrestrictionsasadoptedbyreferenceinWAC173303140,determineifthewasteexhibits
anydangerouswastecharacteristics,WAC173303090;and

(iv)Fourth,ifthewasteisnotlistedinWAC173303081or173303082,anddoesnotexhibitacharacteristicin
WAC173303090,determineifthewastemeetsanydangerouswastecriteria,WAC173303100.

(b)Apersonmustcheckeachsection,intheordersetforth,untiltheydeterminewhetherthewasteis
190
designatedasadangerouswaste.Oncethewasteisdeterminedtobeadangerouswaste,furtherdesignationis
notrequiredexceptasrequiredbysubsection(4)or(5)ofthissection.Ifapersonhascheckedthewasteagainst
eachsectionandthewasteisnotdesignated,thenthewasteisnotsubjecttotherequirementsofchapter173
303WAC.

AnypersonwhowishestoseekanexemptionforawastewhichhasbeendesignatedDWorEHWmustcomply
withtherequirementsofWAC173303072

Generally,DRUGSARENOWCONSIDEREDTOBEDANGEROUSWASTE,andinWashingtonMAY
NOTBEDISPOSEDOFINSEWERS(e.g.,byflushingdownthetoilet)orinSANITARYLANDFILLSorOTHERWASTE
DISPOSALSITES.UponinputfromtheBoardofPharmacy,theDOEhasexemptedcontrolledsubstances,legend
drugs,andOTCdrugsfrommostofitsregulationswhentheyaredisposedofbyapersonorentitylicensedto
possessthem,providedtheyaredisposedofinanapprovedincineratororafacilityapprovedtoincinerate
municipalwaste.WAC173303071(3)(nn)(i)
STATEONLYHAZARDOUSWASTE.Theseregulationsaffectonlystateonlyhazardoussubstances.Somedrugs
areclassifiedunderfederallawashazardouswasteandthestatecannotexemptthesedrugsfromfederal
requirements.(Seeabove).
INCINERATORS.Hospitalsmayoperateapprovedincinerators,andhospitalpharmacistsmaybeabletouse
thesefacilities.
REVERSEDISTRIBUTORS.Pharmaciesareincreasinglyrelyingonreversedistributorstohandlepharmaceutical
returns.Anyproductthatcanbereturnedtothemanufacturerforcreditiscalledaviablepharmaceutical.A
productdisposedofwithoutreceivingcreditisnonviable.TheDOErulesindicatethatpharmaciesmayreturn
viablepharmaceuticalsusingareversedistributor,andmayalsouseaDEAregisteredreversedistributorto
disposeofnonviablecontrolledsubstances.(Seealsochapter5)Otherpharmaceuticalwastemustbesenttoa
properlyregisteredincinerator.TheBoardhasadvisedpharmaciststomakesurethattheyobtainconfirmation
fromtheirreversedistributorthatitwilldisposeofdrugsinaccordancewithWAlaw,sincethepersonwho
arrangesforthedisposalofhazardouswasteisultimatelyresponsibleifthewasteisnotdisposedofproperly.
CONDITIONALEXCLUSIONTheDOEconsidersspecialwastestobethosewastesthatposearelativelylow
hazard.UnderDOEguidelines,certainpharmaceuticalsareconsideredspecialwastesthatcanbehandled
undertheConditionalExclusion.
INTERIMENFORCEMENTPOLICYInApril2008,theDOEpublishedanInterimEnforcementPolicyfor
PharmaceuticalWasteinHealthcare318underwhichitwillrefrainfromenforcingportionsoftheDangerous
WasteRegulationsatfacilitiesmeetingtheconditionsofthispolicy.ThepolicyistoremainineffectuntilEPA
finalizesitsproposedUniversalWasteRuleforPharmaceuticals.Eligiblefacilitiesincludepatientcarefacilities
andretailpharmacies.ThepolicywasrevisedinOctober2016,andtheDepartmentanticipatespromulgating
revisedrulesin2017.Thepolicyallowscoveredentitiestoaccumulatewasteandforwardthemtoareverse
distributor.Stepsinusingthepolicyinclude:
Createawasteprofilebycharacterizingwasteaccumulatedoveraminimumof90days.Listeachwaste
type(e.g.,warfarin,silvernitrate,cyclophosphamide,etc.)byitswastecodeandestimateitsminimum
andmaximumpercentagebyweightofthetotalwaste.Includeconditionallyexcludedstateonly
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WILLIAME.FASSETT
pharmaceuticalwaste(i.e.,allothernonlistedpharmaceuticalwaste)asasingletotal.Thewaste
profilemustbeupdatedevery3years.
NotifyDOEthatyourfacilityismanagingwasteunderthepolicy,includingacopyofyourcompleted
profile.
Trainstaffinproperhandlingofpharmaceuticalwaste.
AccumulatewasteinaccordancewithDOEguidelines.Wastemaybeaccumulatedforupto180days.
DisposeofWastebyfollowingDOEguidelines.
Viablewasteandnonviablecontrolledsubstancesmaybereturnedusingareversedistributor
Nonviablenoncontrolledsubstancesmaybesubmittedtoaregisteredwastetransporter.
HIPAAREGULATIONSapplytoanyPHIcontainedwithinthewastestream.Wastethatcontainspatient
informationonlabelsmustbestoredandhandledsoasnottobreachapatientsprivacy.(SeealsoChapter6)
TheDepartmentofEcologyhasestablishedaPHARMACEUTICALSWEBSITEtoassistmedicalfacilitiesin
managementofdangerouswastes,includingpharmaceuticals,IVadmixtures,andsharps.Itcanbefoundat
http://www.ecy.wa.gov/programs/hwtr/pharmaceuticals/index.html.SpecificBestManagementPracticesare
listedforvariouscategoriesofpharmaceuticalwasteat
http://www.ecy.wa.gov/programs/hwtr/pharmaceuticals/pages/bmp.html.
PATIENTDISPOSALOFDRUGS
Thehazardoussubstancesrulesapplyingtodrugsinthepossessionofwastegenerators(e.g.,pharmaciesand
hospitals)donotapplytoprivatecitizens.
ThePharmacyCommissionallowspharmaciestocomplywithDEAapproveddrugreturnprograms.Asnoted
above,theCommissionswebpagehasaguidancedocumentthatpharmaciesshouldreadandadhereto.
RESIDENTSOFSPOKANE,WAmaydiscarddrugsandsyringesintheirresidentialgarbage,becauseSpokane
incineratesallitsmunicipalwasteinitsuniqueWastetoEnergyFacility.
KINGCOUNTYresidentsmaytakeunwantedmedicationstosecurelockboxeslocatedthroughoutthecounty
andfundedundertheCountysextendedproductresponsibilityordinance(seebelow).Amapshowingdropbox
locationsisavailableathttps://kingcountysecuremedicinereturn.org.
Residentsofmostothercommunitiesmaynormallytakemedicationstothehazardouswasteareaoftheirlocal
landfillortransferstation.Theyshouldbeadvisedtocalltheirlocalwastemanagementauthorityfor
instructions.
FEDERALLEGISLATION.In2010,CongresspassedS.3397theSecureandResponsibleDrugDisposalActof
2010,whichamendedtheCSAtoallowanauthorizedusertoreturntoanapprovedagenthisorherunused
controlledsubstancesfordisposal,underregulationstobedevelopedbyDEA.319
TheDEAissuedafinalruleonSeptember9,2014,whichbecameeffective30dayslater.Theruleallows
pharmaciestoregisterascollectorsofdrugsandcontrolledsubstancesdepositedbypatientsintoapproved
containers,and/ortoprovidesuchcontainerstonursinghomesforthedisposalofresidentsdrugs.Pharmacies
mayalsoparticipateinmailbackprograms.320(SeealsoChapter5)
EXTENDEDPRODUCERRESPONSIBILITY(EPR)LAWS
ExtendedProducerResponsibility(EPR)isapolicybywhichaproductsproducercontinuestobearfinancial
and/orphysicalresponsibilityforaproductduringthepostconsumerstageofaproductslifecycle.Inother
192
words,theproducerismaderesponsiblefortheenvironmentallysafedisposalofaproductafteritsusefullifeis
over.PassageofEPRlawsbystatesbeganin2000,primarilywithstatutesconcernedwithelectronicproducts.
STATELEGISLATION.Washingtonbecamethe3rdstateinthenationtopassanEPRlawrelatedtoelectronic
productsin2006.Asecondstatute,dealingwithmercurycontainingproducts(seebelow)waspassedin2010.
The2009WashingtonLegislaturealsoconsidered,butdidnotpass,HB1165,whichwouldestablisha
pharmaceuticalproductstewardshipprogram(i.e.,aconsumertakebackprogram)fundedandprovidedby
drugproducers.AsofFebruary2010theStateSenatewasconsideringitscompanionbill,SB5279.Bothbills
wereretainedtobereintroducedinthe2011legislature.Asof2017,noactionhasbeentaken.
LOCALLEGISLATION.KingCounty(WA)InJune2013theKingCountyBoardofHealthpassedaregulationto
createadrugtakebackprogramforcountyresidents.BasedonsimilarordinancesinAlamedaCounty,CA,the
regulationrequiresproducersofprescriptiondrugssoldinKingCountytocreateaproducerfundedtakeback
program,whichisnowineffect.
TheAlamedaCountyordinancewaschallengedinfederalcourt.InSeptember2014,the9thCircuituphelda
lowercourtsrejectionofthelawsuitandtheU.S.SupremeCourtdeclinedtohearanappeal.321
HANDLINGOFHAZARDOUSDRUGSINPHARMACIESANDOTHER
PATIENTCAREFACILITIES
WORKPLACESAFETYRULESAREDESIGNEDTOPROTECTEMPLOYEESFROMWORKPLACE
HAZARDS.
Washingtonemployersarerequiredtoprovideemployeesaworkplacefreefromrecognizedhazardsthatare
causing,orlikelytocause,seriousinjuryordeath.(WAC29680011005).Amongthesemanyrulesareanumber
thataffectpharmacies.Employersmust
ProhibitemployeesfromworkingwhoareundertheINFLUENCEOFALCOHOLORNARCOTICS.(WAC
29690011025)
CONTROLCHEMICALAGENTSinamannerthattheywillnotpresentahazardtoyourworkers;or
protectworkersfromthehazardofcontactwith,orexposureto,chemicalagents.(WAC296800
11040)
ProtectemployeesfromexposuretohazardousconcentrationsofBIOLOGICALAGENTSthatmayresult
fromprocessing,handling,orusingmaterialsorwaste.(WAC29680011045).Thisappliestoexposure
tobiologicagentsduringcleanup,orothertasks,whereemployeeshandleANIMALSORANIMALWASTE
orbodyfluids.
EmployersmustWARNEMPLOYEESOFBIOHAZARDSusingappropriatetagsorsignage
SPECIFICRULESEFFECTIVEIN2015FORHEALTHCARESETTINGSRELATINGTOHANDLING
OFHAZARDOUSDRUGS.
Astatutepassedin2011322requirestheDepartmentofLabor&Industriestoadoptrulesimplementingthe2004
NIOSHSafetyAlertonsafehandlingofhazardousdrugs.Washingtonwasthefirststateinthenationtoenact
protectionforhealthcareworkers.323Considerableinputbyhealthcareprovidershasbeenmadetothe
Department,whichpublishedfinalrulesinJanuaryof2014.
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WILLIAME.FASSETT
Enforcementoftheserules(WAC29662500andfollowing)wasdelayeduntilJanuary2015.324Therulesapply
toallemployersinhealthcarefacilitiesregardlessofthesetting.Onlythehazardousdrugsbeingusedinthe
workplacearecoveredbytherule.
COVEREDOCCUPATIONS.TheDepartmentbelievesthatthefollowingoccupationsmayinvolveexposuresto
hazardousdrugs.
Pharmacistsandpharmacytechnicians
Physiciansandphysicianassistants
Nurses
Patientcareassistivepersonnel
Operatingroompersonnel
Homehealthcareworkers
Veterinariansandveterinarytechnicians
Environmentalservicesemployees
Employeesinhealthcarefacilitieswhoshiporreceivehazardousdrugsfromthemanufactureror
distributor.
COVEREDDRUGS.HazardousdrugscoveredintherulearethoseontheNIOSHlist,foundat
www.cdc.gov/niosh/docs/2012150/pdfs/2012150.pdf.
Drugswereplacedonthelistduetopotential:
Carcinogenicity
Teratogenicityorotherdevelopmentaltoxicity
Reproductivetoxicity
Organtoxicityatlowdoses
Genotoxicity
Newdrugswithstructureandtoxicityprofilesthatmimicexistinghazardousdrugs
Thedrugsonthe2012listincludemanyobviousagents,suchaschemotherapyandantineoplasticagents(eg,
azathioprine,carboplatin,dactinomycin,andmethotrexate).Otherdrugsincludecarbamazepine,clonazepam,
paroxetine,risperidone,andzoledronicacid.
WRITTENHAZARDOUSDRUGSCONTROLPROGRAM.Eachfacilitymustestablishahazardousdrugcontrol
program,consistingatleastofthefollowing:
AWRITTENINVENTORYofcoveredhazardousdrugsintheworkplace
AcompletedHAZARDASSESSMENTFOREACHDRUGwhichanticipatesreasonablyanticipated
occupationalexposure(s)tothedrug.Specificrequirementsforconductingahazardassessmentare
foundinWAC2966250020.
HAZARDOUSDRUGPOLICIESANDPROCEDURESdesignedtopreventemployeeexposuretohazardous
drugs(WAC2966250015).Thepoliciesshouldconsider
o Engineeringcontrols
o Provisionofpersonalprotectiveequipment(PPE)whennecessary
o Safehandlingpracticesduring
Receiving
Storage
Labeling
194
Preparing
Administering
Disposal
o Cleaning,housekeeping,andwastehandling
o Spillcontrol
o Personnelissues(eg,exposureofpregnantworkers)
o Training
ANNUALREVIEWANDUPDATEoftheprogram,andupdatewhenchangesoccur
EmployersmustseekandCONSIDERINPUTFROMEMPLOYEES
AVAILABILITYOFADEQUATEFACILITIES,INCLUDINGVENTILATEDCABINETS
Detailedrulesrelatingtoengineeringcontrols,PPE,safehandlingpractices,cleaningandhousekeeping,spill
control,andtrainingareinWAC2966250025through50050.
Specificguideshavebeendevelopedfordifferentprofessions,includingoneforpharmacy,andareavailableat
http://www.lni.wa.gov/safety/topics/atoz/hazardousdrugs/programguides.asp
USP<800>HANDLINGOFHAZARDOUSDRUGSINHEALTHCARESETTINGS.TheUnited
StatesPharmacopoeia(USP)hasadoptedachapteronhandlingofhazardousdrugs(HDs)inhealthcaresettings,
whichisdesignedinparttosupplementtherequirementsofUSP<797>oncompoundingofsterileproducts.
TheimplementationdateofthechapterhasbeendelayedtoJuly1,2018.Thechapterappliestoallhealthcare
personnelwhohandlehazardousdrugpreparations,notjustpharmacypersonnel.Asnotedabove,theessential
elementsofUSP<800>arealreadyapplicabletopharmaciesinWashingtonstate.
COVEREDSUBSTANCES.
AhazardousdrugisadrugontheNIOSHlistdiscussedabovethatis:
o AnyHDAPI(activepharmaceuticalingredient)
o AnyantineoplasticrequiringHDmanipulation
DrugsonNIOSHlistarenotincludedifanassessmentofriskisperformedandimplemented,andthe
drugisfoundtobe:
o AfinaldosageformofcompoundedHDpreparations;or
o AfinaldosageformofconventionallymanufacturedHDproducts;and
o Donotrequireanyfurthermanipulationotherthancountingorrepackaging
COVEREDINDIVIDUALSANDENTITIES.
AllhealthcarepersonnelwhohandleHDpreparations,includingbutnotlimitedto:
o Pharmacists
o Pharmacytechnicians
o Nurses
o Physicians
o Physicianassistants
o Homehealthcareworkers
o Veterinarians
o Veterinarytechnicians
Allentitiesthatstore,prepare,transport,oradministerHDs,includingbutnotlimitedto:
o Pharmacies
o Hospitalsandotherhealthcareinstitutions
o Patienttreatmentclinics
195
WILLIAME.FASSETT
o Physicianspracticefacilities
o Veterinariansoffices
NotcoveredbyUSP<800>aremanufacturers,wholesalepersonnel,researchers,orfamilymembersof
coveredindividuals.
MAJORPROVISIONS.Theintroductionandanother17sectionsofthechapteroutlinethepracticeandquality
standardsforhandlinghazardousdrugstopromotepatientsafety,workersafety,andenvironmental
protections.Coveredindividualsandentitiesshouldreviewthechapterdirectly.Eachcoveredentitymust
developaprogramcoveringthefollowingelements:
Introductionandscope
ListofHDs
Typesofexposure
ResponsibilitiesofpersonnelhandingHDs
Facilitiesandengineeringcontrols,includingdesignatedareasforreceiptandunpacking,storage,non
sterilecompounding(mustfollowUSP<795>),andsterilecompounding(mustfollowUSP<797>)
o HDsmustbereceivedandunpackedinneutral/negativepressurearea
o Mustbestoredsoastopreventspillageorbreakage
o ContainmentPrimaryEngineeringControls(CPEC)includesthecabinettypesneededfor
compoundingmayinclude
ClassIIBiologicalSafetyCabinets(TypeA2,B1,orB2)
CompoundingAsepticContainmentIsolators(CACI)
ContainmentVentilatedEnclosures/PowderHoods
o ContainmentSecondaryEngineeringControls(CSEC)relatestotheroominwhich
compoundingisdone
Externallyvented
Physicallyseparated
Negativepressure
Sink
Eyewashstation
o Supplementalengineeringcontrolsincludeclosedsystemtransferdevices(CSTDs),whichare
requiredforadministrationandrecommendedforcompounding
o MustfollowCPECstandardsformanipulation,includingcrushingofdosageforms
Environmentalqualityandcontrolincludesinitialsamplingandroutinesampling(every6months
recommended)
PersonalProtectiveEquipment(PPE)
o Headcovers
o Beardcovers
o Eyeprotectionforspillprotection
o Facemasklimitedsafetyprotection
o Poweredairpurifyingrespiratorforspills
o Disposablegowns,mustbepolyethyleneorlaminate
o 2pairsofgloves
o 2pairsofantiskidshoecovers,don2pairspriortoentry,discardouterpairwhenleaving
Hazardcommunicationprogram
o Writtenplan
o AllcontainersofHDsmustbelabeled
196
o MusthavesafetydatasheetforeachHD
o SDSmustbereadilyavailabletopersonnel
o Informationandtrainingmustbeprovidedbeforejob
o Personnelcapableofreproductionmustconfirminwritingtheyunderstandreproductiverisks
ofhandlingHDs
Personneltraining
o Allpersonnelmustbetrained
o Allpersonnelmustbeassessedevery12months
o MustbetrainedonnewHDsandequipment
o Mustdocumentcompetencies
ReceivingHDs
o Mustbeaneutralornegativepressurearea
o GloveswornforunpackingHDs
o Spillkitavailable
o VisualinspectionforHDs
o Anydamagedpackagesconsideredaspill
Labeling,packaging,transport&disposal
o AlltransportedHDsmustbelabeledwithHDprecaution
o MustnottransportHDliquidsviapneumatictubes
Dispensingfinaldosageforms
o AnycountingorpackagingequipmentmustbecleanedaftereachuseforanHD
o NOANTINEOPLASTICDRUGSINAUTOMATEDCOUNTINGORPACKAGINGMACHINES
o Mayputantineoplasticdrugsinautomateddispensingcabinets
Compounding
o FollowUSP<795>or<797>
o ShoulduseCSTDforsterilecompounding
o Shouldusechemomat
o MustdedicatespecialequipmentforHDs
Administering
o MustuseCSTDsorprotectivemedicaldevicesandtechniques
o MustpreprimeIVtubingwithnonHDsolution
o MustwearPPE
o Mustavoidmanipulation(splitting,crushing,openingcapsules)
Deactivating,decontaminating,cleaninganddisinfecting
o 2%sodiumhypochloritesolutionfordeactivation
o Physicalsurfacewipewithsodiumthiosulfatesolutionfordecontamination
o Cleanwithtriorquadrivalentdetergentorreadytouse(RTU)peroxide
o Disinfectionwithsterile70%isopropylalcoholand/orUVlight
Spillcontrol
o PropertraininginuseofPPE,respirators,andspillkits
o Spillsignsposted
o Readilyavailablespillkits
o Disposeofspillkitsashazardouswaste
o Policiesandtrainingmustaddressspillsize
DocumentationandSOPsreviewedevery12months
Medicalsurveillance
197
WILLIAME.FASSETT
o Individualpersonnelshouldbeidentifiedastoriskofexposureattimeofhireandroutinely
thereafter
o Provideforpostexposureexamination
o Conductenvironmentalsampling
o Verifyengineeringcontrolsareworking
o ConductFMEAofprocessesandpolicies
o Developactionplan
o Ensureconfidential2waycommunication
o Providecontinuingmedicalsurveillance
EXTEMPORANEOUSCOMPOUNDINGOFDRUGPRODUCTSBY
PHARMACISTS
PHARMACIESEXEMPTFROMREGISTRATIONWITHFDA.Extemporaneouscompoundingof
medicationsisalongstandingaspectofthepracticeofpharmacy.WhentheFDCAwasadoptedin1938,
manufacturerswererequiredtoregisterwiththeFDA.
510(b)requiresannualregistrationbyeverypersonengaginginthemanufacture,preparation,propagation,
compounding,orprocessingofdrug[s]...
However,510(g)exemptsfromregistrationpharmacies...regularlyengagedindispensingdrugsanddevices
...andwhichdonot...compound...drugsotherthanintheregularcourseoftheirdispensingorsellingdrugsat
retail...
COMPOUNDINGPHARMACIESMAYSTILLBEVIEWEDASMANUFACTURERSUNDERSTATE
PRODUCTLIABILITYLAWS.
AlthoughcompoundingpharmaciesarenottreatedasmanufacturersundertheFDCA,theyremainliablefor
defectsintheproductstheyproduce.Unlikelawsregardingsuitsforprofessionalnegligence,productliability
lawsmayimposeliabilityontheentitythatintroducestheproductintothestreamofcommerceforanyproduct
defect,whetheritwasforeseeableornot.(SeealsoChapter7)
PHARMACIESMUSTBEENGAGEDINBONAFIDEPHARMACYOPERATIONS.
Untilthe1980s,theFDAandmostcommentatorsbelievedthatpharmacistscouldcompoundanymedication
orderedbyaphysicianwithoutviolatingtheFDCA.Somepharmaciesbegantoexpandtheircompounding
businessgreatly,andafewusedtheexcusethattheywerecompoundingdrugstoshieldthemfromregulation
forsomepotentiallyoractuallyharmfulpractices.
Forexample,theSevenFreedomsPharmacyinFloridacompoundedaproductcalledGH8,andshippedthe
productaroundtheUnitedStatesviathemail.GH8consistedofaformulationofprocaine,anditwasallegedto
retardagingreduceoreliminatemanyofthesymptomsofaging.GH8wastheonlyproductcompoundedor
soldbySevenFreedomsPharmacy,andthepatientsjoinedClubSeneXtoreceiveprescriptionsforGH8,orto
receiveinstructionsfortheirownphysiciantoprescribeGH8.Inalandmarklawsuit,325theUSCourtofAppeals
ruledthatSevenFreedomsPharmacywasnotengagedinthebonafidepracticeofpharmacy,thatGH8wasa
newdrugthathadnotbeenapprovedbytheFDA,andthatitsdistributionviolatedtheFDCA.
198
Injuriesfrompoorlycompoundedprescriptionsincludedoverdosesofpediatricmedications,blindnessfrom
nonsterilecompoundedeyedrops,anddeathsduetomeningitiscausedbynonsterilebetamethasone
injection.FDAsurveysin2001discoveredseveralproblemsinarandomselectionofcompoundedproducts.
CHANGESINFDASVIEWOFCOMPOUNDING.Inresponsetotheseevents,theFDAreexaminedits
positionthatcompoundingwasexemptfromFDAoversight.Itdeterminedthat,althoughpharmaciesdonot
needtoregister,510(g)doesnotexemptpharmaciesfromthenewdrugrequirementsoftheAct,which
includethefollowingthreesections:
501(a)(2)(b)AdrugisadulteratedifitisnotmanufacturedinaccordancewithCurrentGood
ManufacturingPractices(GMPs).
502(f)(1)Adrugismisbrandedifitlacksadequatedirectionsforuse.
505AnapprovedNewDrugApplicationisrequiredbeforeanewdrugcanbemarketedor
introducedintothestreamofcommerce.
Thus,theFDAdetermined,compoundedproductsarenewdrugs,whichcomeunderitsjurisdiction.Overnearly
2decades,litigationandlegislationunsuccessfullyclarifiedtheroleofcompoundedpharmaceuticalsintheUS,
andcompoundinglargelywasregulatedbystatesandsporadicFDAaction.
FDAGUIDANCEONPOSSIBLEMELAMINECONTAMINATION.Thepresenceofmelaminecontaminationin
Chineseproducedcomponentsusedinanimalfoodgainedsignificantpublicityin2008.InAugust2009,theFDA
issuedaguidance326toalertpharmaceuticalmanufacturersandpharmacycompounderstothepossible
contaminationbymelamineofpharmaceuticalcomponents.Itsuggeststhatcompoundersshould
independentlytestcomponentsforpossiblemelaminecontamination,orpurchasesuchcomponentsonlyfrom
reliablesupplierswhohaveperformedsuchtesting.Becausethetestinginvolvesliquidorgaschromatography
combinedwithmassspectrometry(LCMS/MSand/orGCMS),themostpracticalresponseofpharmacy
compoundersistopurchaseonlycomponentsthatarecertifiedmelaminefreebyareputablesupplier.Example
atriskcomponentslistedbytheFDAincludecertainaminoacids,gelatin,guargum,andlactose,amongother
items.Theadviceintheguidanceisgenerallynonbinding.Failureofacompoundingpharmacytoactin
responsetothisannouncement,however,couldbeseenasevidenceofnegligenceifapatientwereinjured.
CHALLENGESTOBIOIDENTICALHORMONEREPLACEMENTTHERAPY.
Inearly2008,Wyethfiledacitizen'spetitionaskingtheFDAtotakeenforcementactions,includingseizures,
injunctionsand/orwarningletters,againstpharmaciesengagedincompoundingofsocalledbioidentical
hormonereplacementtherapy(BHRT).AmongtherequestedactionswerethatpharmaciescompoundingBHRT
mustprovideapatientpackageinsert,notingthatBHRTisnotFDAapproved,isnotmanufacturedaccordingto
goodmanufacturingpractices,andthattheBHRThasnotbeendemonstratedtobesafeforeffectiveforany
use.WyethalsorequestedthattheFDAissueanalertortalkpaperdirectedtoconsumers,healthcareproviders
andthecompoundingindustry.FDAlimiteditsactionsinresponsetothecitizenspetitiontodevelopinga
consumerawarenesscampaign,publishinganarticleonitswebsite,issuingapressrelease,andarrangingcalls
withmediaandstakeholderstodiscusstheissues.327
Atthesametime,theFDAindependentlysentwarninglettersto7compoundingpharmaciesthatwere
promotingBHRTontheirwebsites.IngeneraltheFDAraisedthreetypesofissuesrelatingtothepharmacies'
websiteclaims:
unsubstantiatedtherapeuticclaims,suchas"bioidenticalestrogenreplacementtherapycanbenefita
womanbyreducingriskofheartdisease,reducingtheriskofAlzheimer's";
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WILLIAME.FASSETT
unsubstantiatedsuperiorityclaims,suchas"bioidenticalhormonesdifferfromsynthetichormonesin
thatsyntheticsarenotidenticalineitherstructureorfunctiontothenaturalhormonestheyemulate
";and
unsubstantiatedbioidenticalclaims,whichsuggeststhatcompoundedhormonetherapydrugsare
naturaloridenticaltothehormonesmadebythebody.
ItseemsclearthatthepharmaciescametotheFDA'sattentionprimarilybecauseoftheirwebsites,andthe
claimsmadetherein.TheFDAwascarefultonotethatthisactiondidnottargetpharmacistwhopractice
traditionalpharmacycompoundinganddonotmakefalseormisleadingclaimsaboutcompoundedproducts."328
NEWENGLANDCOMPOUNDINGCENTERINCIDENT.InearlySeptember2012,patientsbeganarrivinginUS
hospitalswithararevarietyoffungalmeningitis.ATennesseephysician,Dr.AprilPettit,contactstheTennessee
HealthDepartmentafteridentifyingfungusinapatientsCSF,seekingtoseeiftherewereotherreports.Dr.
PettitthusuncoveredanoutbreakoffungaldiseasethatbyFebruary2013wouldsicken696patientsandcause
45deaths.329Thediseasewastracedtolotsofpreservativefreemethylprednisoloneacetateinjectionprepared
andsoldtophysiciansforintrathecalinjectionbytheNewEnglandCompoundingCenterinFramingham,
Massachusetts,andwasprimarilyduetoExserohilumrostratum,acommonmoldthatrarelycausesdiseasein
humans.NECCoperatedunderapharmacylicense,butinvestigationsrevealedthatitdidnotappeartocomply
withtherequirementofapharmacistpatientphysicianrelationship,nordiditadheretoUSP<797>quality
controlrequirements.SomecommentatorsonthesituationsuggestedthattheWesternStatesdecisionhadthe
effectofweakeningFDAoversightandfederalstatecooperation.330APhA,aswellasotherpharmacy
organizations,notedthatcompoundingintherecognizedcontextofapatientpharmacistphysicianrelationship
isaneededprofessionalserviceregulatedunderstatelaw,andthatboththeUSPstandardsaswellas
accreditationstandardssupportsafeandeffectivepharmacycompounding;nevertheless,APhAexpresseda
needforimprovedstateandfederalregulationofillegalmanufacturerswhodonotcompoundwithin
professionalstandards.331
COMPARISONOFCOMPOUNDINGPHARMACYVS.
DRUGQUALITYANDSECURITY OUTSOURCINGFACILITY
ACT.CongressrespondedtotheNECC
COMPOUNDING OUTSOURCINGFACILITY
incidentbyenactinglegislationin2013.The
PHARMACY (503B)
firstpartoftheDQSAdealtwithissues (503A)
relatedtopharmacycompoundingas
discretefromlargevolumecompoundingof INDIVIDUALPRESCRIPTION Required Optional
unapprovedsteriledrugs. SUBJECTTOGMPS No Yes
SECTION503AREENACTED.TheAct WHOLESALING Subjecttostate Prohibitedbyfederal

reinstatestheformer503Ainfullexcept laws law
forthepreviousprohibitionsonadvertising
REGISTRATIONWITHFDA No Yes
and/orsolicitationofprescriptions,asit
appliestotraditionalpharmacy REPORTING No Yes
compounders(seebelow).
FEES None $16,852annual
registration($5,279
SECTION503BREGARDING smallbusiness);
OUTSOURCINGFACILITIES.Congress $15,837reinspection
establishedamechanismbywhichentities
engagedinlargevolumecompoundingofsterileproducts(orotherdrugsnototherwiseapprovedfor
marketing)couldvoluntarilyregisterwithFDAandbeexemptfromNDAoradequatelabelingrequirementsof
200
theFDCA.Theseentities,however,wouldbesubjecttocurrentGMPregulationsdevelopedtoapplytotheir
activities.Theoutsourcingfacilitymustbeunderthesupervisionofalicensedpharmacist,butwouldnot
necessarilyneedtobeapharmacy.
TheFDAhasreiteratedthatundercurrentlaw,theonlysourceofcompoundedproductsforofficeuse
withoutcompoundingpursuanttoindividualprescriptionsisanoutsourcingfacility.TheFDAfurthernotesthat
anoutsourcingfacilitymustdosomesterilecompoundingtoqualifyforregistration,butmaydononsterile
compoundingaswell.
TheFDAswebsiteoncompoundingisausefulresourceforpharmacistsregardingthefederallaw
(www.fda.gov/drugs/GuidanceComplianceRegulatroyInformation/PharmacyCompounding).
SECTION503AREQUIREMENTS
Pharmaciesdulylicensedbyastate,andengagedinthegoodfaithpracticeofpharmacy,maycompound
prescribeddrugproductsthatarenotnewdrugssubjectto501(a)(2)(B),502(f)(1),or505oftheFDCA,if
theyfollowallofthefollowingrequirements.
RECEIPTOFAPRESCRIPTIONFORANINDIVIDUALIDENTIFIEDPATIENTREQUIRED.501(a)(2)(b),502(f)(1),and
505donotapplytodrugsthatarecompoundedforanindividualidentifiedpatient,basedonthereceiptofa
validprescription.TheFDAissuedaguidance332inDecember2016statingthatavalidprescriptionorder
includes
Aprescriptionissuedbyanauthorizedprescriber;
Validorderornotationmadeinapatientshealthrecordinaninstitutionalsetting;or
Avalidorderornotationmadebyaphysicianwhocompoundsadrugforhisorherownpatientand
notedinthepatientsmedicalrecord.
Theordermustidentifythespecificpatient.Anorderspecifyingacompoundedprescriptionnamingthe
prescriberasthepatientisonlyvalidifthecompoundedproductistobeadministeredtotheprescriber,
ratherthansomeotherpatient.
Notwithstandingstatelawswhichmayallowcompoundingofprescriptionsthatdonotnamea
particularpatient,orthatallowcompoundingforgeneralphysicianofficeuse,theFDAreiteratedinits
2016guidancethatcompoundingforofficeusemayonlybedonebyoutsourcingfacilities,unlessthe
compoundingisdoneforaspecificnamedpatient.
LIMITEDQUANTITIESMAYBECOMPOUNDEDPRIORTORECEIVINGAPRESCRIPTION,basedonahistoryofthe
pharmacistreceivingvalidorderswithinanestablishedrelationshipbetweenthepharmacist,physician,and
patient.Inits2016guidance,theFDAspecifiedthatthismeansthatanticipatorycompounding...isdonein
limitedquantities,basedonanexpectationthatthelicensedpharmacist...willreceiveapatientspecific
prescriptionfortheparticulardrugproduct,writtenforapatientorbyaprescriberwithwhomthecompounder
hasarelationship.TheFDAwillnotassertthatthecompounderiscompoundingexcessivequantitiesin
violationoftheActif:
Thecompounderholdsfordistributionnotmorethananestimated30daysupplyofaparticular
compoundedproduct;i.e.,theamountthecompounderreasonablyexpectstoneedtofillorders
receivedovera30dayperiod;and
Theamountofaparticularcompoundedproductneededisbasedonthenumberofvalidprescriptions
receivedovera30dayperiodselectedbythecompounderfromtheprioryear.
COMPONENTSANDMETHODSusedtocompoundtheproduct
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WILLIAME.FASSETT
MustcomplywithUSPorNFmonographs,iftheyexist,andtheUSPChaptersonPharmacy
Compounding.
Ifnomonographsexist,theproductsmustbemadefromcomponentsofapproveddrugs,or
MustbecomponentsthatappearonabulkingredientslistdevelopedbyFDA.InDecember2016,the
FDAissuedaproposedruleonthistopic,containingthefollowing6ingredients:333
o BrilliantBlueG,a/k/aCoomassieBrilliantBlueG250
o cantharadin(fortopicaluseonly)
o diphenylcyclopropenone(topicaluse)
o NacetylDglucosamine(topicaluse)
o squaricaciddibutylester(topicaluse)
o thymoliodide(topicaluse)
ItisnotclearifthisproposedruleissubjecttoanexecutiveorderissuedbyPresidentTrumprelatingto
regulationspromulgatedinthefinal60daysoftheObamaadministration.
MustbemanufacturedinanFDAregisteredfacility
PROHIBITEDPRODUCTS.Pharmacistsareprohibitedfromcompoundingcertainproducts:
MaynotcompoundproductsthatarelistedbyFDAashavingbeenremovedfrommarketduetolackof
safetyorefficacy[currentfinalrulepublishedOctober7,2016;21CFR216.24].
Maynotcompoundregularlyorinaninordinateamountproductsthatareessentiallycopiesof
commerciallyavailabledrugproducts.
MaynotcompoundproductsthatarelistedbyFDAashavingdemonstrabledifficultiesincompounding
[listtobedeveloped].
USPCHAPTERREVISIONS.TheUSPhasdevelopedthreechaptersrelatedtocompounding,including
chapter<800>,discussedabove.
COMPOUNDINGOFNONSTERILEPRODUCTSCHAPTER<795>.Chapter<795>ofUSP27,relatestogeneral
standardsofcompoundandtocompoundingofnonsterileproducts,andcoversmostcompoundingactivitiesof
communitypharmacies.
CHAPTER<795>STANDARDS.
Amongthestandardsofchapter<795>arethefollowinggeneralrequirements.
STABILITYANDEXPIRATIONDATING
Appropriatestabilityevaluationisperformedordeterminedfromtheliteratureforestablishingreliable
beyondusedating.
Beyondusedatesaretobeassignedconservatively.
Intheabsenceofstabilityinformationthatisapplicabletoaspecificdrugandpreparation,thefollowing
maximumbeyondusedatesarerecommendedfornonsterilecompoundeddrugpreparationsthatarepackaged
intight,lightresistantcontainersandstoredatcontrolledroomtemperatureunlessotherwiseindicated:
ForWaterContainingFormulations(preparedfromingredientsinsolidform)Thebeyondusedateis
notlaterthan14daysforliquidpreparationswhenstoredatcoldtemperaturesbetween2and8(36
to46F).(27USP2347)
Fornonaqueousliquidsandsolidformulations
202
o Wherethemanufactureddrugproductisthesourceoftheactiveingredientthebeyonduse
dateisnotlaterthan25%ofthetimeremaininguntiltheproductsexpirationdateor6months,
whicheverisearlier.
o WhereaUSPorNFsubstanceisthesourceoftheactiveingredientthebeyondusedateis
notlaterthan6months.
o Forallotherformulationsthebeyondusedateisnotlaterthantheintendeddurationof
therapyor30days,whicheverisearlier.
LABELING.TheUSPspecifiesthat,aspartofthecompoundingprocess,thecompoundershouldlabelthe
prescriptioncontainerstoincludethefollowingitems:a)thenameofthepreparation;b)theinternal
identificationnumber;c)thebeyondusedate;d)theinitialsofthecompounderwhopreparedthelabel;e)
anystoragerequirements;andf)anyotherstatementsrequiredbylaw.
COMPOUNDINGOFSTERILEPRODUCTSCHAPTER<797>.Thesecondmonograph,chapter<797>ofUSP39,
detailsgoodpracticesforcompoundingofsterileproducts,whichincludeshomeIVadmixtures,eyedrops,and
similarproducts.Thestandardsinthesechapterswereincorporatedbyreferencein503A.Everypharmacy
engagedinsterilecompoundingmustmaintainacurrentversionofchapter<797>andadheretoits
requirements.WiththeadoptionofUSP<800>,USP<797>wassignificantlyrevisedtofocusprimarilyon
maintainingthequalityandsterilityofthecompoundedproduct,andtherevisedversionwillbecomeeffective
whenUSP<800>becomeseffective.Untilthattime(July2018),theolderversionofUSP<797>detailsmanyof
theelementstoprotectpersonnelinvolvedincompoundingfromhazardousdrugs.Therevisedchaptercontains
thefollowingmajorelements:
Introductionandscope
Personnelqualificationstraining,evaluation,requalification
PersonalhygieneandPPEs
Buildingandfacilities
Environmentalmonitoring
Cleaninganddisinfectingcompoundingareas
Equipmentandcomponents
Sterilizationanddepyrogenation
SOPsandMasterFormulationandCompoundingrecords
Releasetesting
Labeling
Establishingbeyondusedatesandinusetimes
Qualityassuranceandqualitycontrol
CSPstorage,handling,packagingandtransport
ComplainthandlingandADRreporting
Documentation
RadiopharmaceuticalsasCSPs
PHARMACYCOMPOUNDINGACCREDITATIONBOARD.In2006,8nationalorganizations(ACA,
APhA,IACP,NABP,NCPA,NASPA,NHIA,andUSP)establishedthePharmacyCompoundingAccreditationBoard
(PCAB).InamannersimilartotheJointCommissionsreviewofhospitals,PCABevaluatescompounding
pharmaciescompliancewithover35standardsandcertifiesqualifiedpharmaciesasmeetingitsstandards.In
particular,pharmaciesthatundertakeanyformsofsterilecompoundingwilllikelyneedtobecomeaccreditedin
ordertoobtainliabilityinsuranceinthefuture.
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WILLIAME.FASSETT
ThePCABhasadoptedlabelingguidelinesforproductsintendedforspecificpatientstotakeoruseathome:
Notificationtothepatientthattheproductiscompounded,includingthenoticethatThismedicinewas
speciallycompoundedinourpharmacyforyouatthedirectionofyourprescriber.
Alllabelsshouldcontainthefollowingelements:
Patient'sname,and/orspecies,ifapplicable;
Prescriber'sname;
Name,address,phonenumberofthepharmacypreparingthemedicine;
Prescriptionnumber;
Themedicationsestablishedordistinctcommonname;
Strength;
Statementofquantity;
Directionsforuse;
Dateprescriptionfilled;
Beyondusedate
Storageinstructions;and
Allstatelabelingrequirements
Anextendedstatementmustaccompanyallcompoundedprescriptions:
Thismedicinewascompoundedspecificallyforyouinourpharmacytofilltheprescriptionyourprescriberwrote
foryou.Itwasspeciallymadetomeetyourindividualneeds.Forthisreason,nostandardizedinformationor
literatureisavailablewithyourprescription.Ifyouhavenotdoneso,pleasediscussthismedicinewithyour
pharmacistorprescribertoassurethatyouunderstand(1)whyyouhavebeenprescribedacompounded
medicine,(2)howtoproperlytakethismedicine,and(3)theinteractions,ifany,thismedicinemayhavewith
anyothermedicinesyouaretaking.
Compoundingisalongstandingpharmacypracticethatallowsprescriberstotreattheirpatientsindividual
needswithoutbeingrestrictedonlytoofftheshelfmedicinesordevices.Thismedicinewaspreparedinour
compoundingpharmacytomeetthespecificationsorderedbyyourprescriber.
1. Callyourpharmacistorprescriberif:
Youexperienceanysideeffects.
Youaretakingadditionalmedicinesthatmayinteractwiththiscompoundedmedicine.
Youhaveallergiesorothermedicalconditionsthatshouldbenoted.
2. Callourpharmacistsif:
Informationonthelabelisnotcleartoyou.
Youhaveanyconcernsregardingprecautions,ingredients,orproperstorage.
Ourpharmacistsareavailabletoaddressanyadditionalquestionsorconcerns.
204
Ifthemedicineiscompoundedforuseinthepractitionersoffice,theprimarylabelmustcontainthestatement,
Thismedicinewascompoundedinourpharmacyforusebyalicensedpractitioneronly.Thiscompounded
preparationmaynotberesold.334
WASHINGTONCOMPOUNDINGSTATUTE
The2013legislaturealsorespondedtotheNECCdebaclebyamendingthePharmacyPracticeActregarding
DrugCompoundingandDistribution.335TheActclarifiesthedefinitionofmanufacturing.
COMPOUNDINGISNOTMANUFACTURING.Distributionofacompoundedproductbyapharmacyforresaleis
manufacturing,notcompounding.However,itallowscompoundingofaspecificproductforresalesubjectto
approvalbythePharmacyCommission.UndertheAct,Manufacturingdoesnotinclude:
Compoundingbyapharmacyon,orinanticipationof,anorderofalicensedpractitionerforuseinthe
courseoftheirprofessionalpracticeforadministrationtopatients;
Repackagingcommerciallyavailablemedicationinsmall,reasonablequantitiesforofficeusebya
practitioner;
Distributionofacompoundedproducttootherappropriatelylicensedentitiesundertheownershipor
controlofthefacilityinwhichthecompoundingtakesplace;or
Thedeliveryoffinishedandappropriatelycompoundedproductsdispensedpursuanttoavalid
prescriptiontoalternativedeliverylocations,otherthanthepatientsresidence,whenrequestedby
thepatient,ortheprescribertoadministertothepatient,ortoanotherlicensedpharmacytodispense
tothepatient.(RCW18.64.011(15))
USP<795>AND<797>INCORPORATEDINTOWASHINGTONLAW.ThestatuteincorporatesUSPchapters
<795>and<797>asstandardsforcompoundingofnonsterileorsterileproductspursuanttoaprescription.
WhenUSP<800>becomeseffective,itwillbeapplicableinWashington,becauseUSP<797>specifies
compliancewith<800>.(RCW18.64.270(2))
Washingtonregisteredentitiesdesiringtobeoutsourcingfacilitiesunderfederallawwillneedtobelicensed
asmanufacturers;theCommissionrequiresoutofstateoutsourcingfacilitiestoregisterasnonresident
wholesalers.
WASHINGTONCOMPOUNDINGRULES.WashingtonPharmacyCommissionregulationsregarding
compoundinggenerallyfollowtheNABPModelAct,andspecifythatpharmacistsmayextemporaneously
compoundproductsorderedforapatientinthecontextofaphysicianpharmacistpatientrelationship.(WAC
246878020).
CURRENTWAC246878.TheCommissionhasnotsuccessfullypromulgatedrevisionstoitscompounding
ruleinresponsetothechangestofederallaw.Thecurrentrulesspecifythefollowing:
DOCUMENTATIONOFPHYSICIANANDPATIENTACCEPTANCEOFCOMPOUNDEDALTERNATIVE.Ifacommercially
availableproductisbeingreplacedbyacompoundedequivalent,recordsmustindicatethatthepatientand
physicianagreetotheuseofthecompoundedproduct,andthisshallbedocumentedontheprescriptionorin
theprescriptionrecords.AnexamplecompoundingworksheetisprovidedattheendofthechapterasAppendix
4B.
SOURCEOFINGREDIENTS.ThefirstchoiceforcompoundedproductsistouseingredientsmeetingUSPorNF
requirements;however,pharmacistsmayusejudgmentifcompendialproductsarenotavailable.
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WILLIAME.FASSETT
LIMITEDQUANTITIES.Productsshouldbecompoundedinlimitedquantities,basedonahistoryofreceiving
prescriptionsfortheproduct,oruponanticipatedneedforrefillsofexistingproducts.Compoundingof
excessivelylargeamountsisconsideredmanufacturing.
WHOLESALINGPROHIBITED.Theregulationprohibitssaleofcompoundedproductstootherlicensedpersonsor
commercialentities.However,itispermittedinWAtosellcompoundedproductstoaprescriberfor
administrationtoapatient.Underfederallaw,suchproductsmustbecompoundedpursuanttoaprescription
forthespecificpatienttowhomthedrugwillbeadministered.
PROMOTIONRESTRICTED,BUTTHISRESTRICTIONNOTENFORCEABLE.Theregulationallowspromotionofthe
compoundingservice,butstatesthattheytheyshallnotsolicitbusiness(e.g.,promote,advertise,oruse
salespersons)tocompoundspecificdrugproducts.(WAC246878020(4)).Asaresultoflegalchallengestoan
earlierversionof503Ainthe9thCircuit,thisprohibitionisunconstitutionalandunenforceable.
PERSONNELREQUIREMENTS.Theregulationspecifiesrequirementsforpharmacistsandancillarypersonnel
involvedincompounding(WAC246878030):
Thepharmacistisresponsibleforinspectingallsupplies,processes,andequipment,andformakingsure
oftheaccuracyofthecompoundingprocess.
Pharmacistsandancillarypersonnelinvolvedincompoundingmustkeepuptodatewithtrainingand
continuingeducation,andbeawareoftherequirementsofWAC246878.
Cleanclothingandappropriateprotectiveapparelarerequired.
Compoundingareasarelimitedtopersonnelinvolvedincompounding,andthepharmacistshallexclude
personswithlesionsorotherillnessesthatmaycompromisetheproduct.
FACILITIES.RequirementsforfacilitiesusedincompoundingarespecifiedinWAC246878040:
Thereshallbeadequatespaceandfacilities,andnonsterilecompoundingshallbeseparatefromsterile
compoundingfacilities.
Bulkcontainersshallbeproperlystored,includingunderrefrigerationifnecessary.
Adequatewaterandothersuppliesmustbeavailableforcompoundingandcleaning.
Facilitiesmustbemaintainedincleanandsanitarycondition.
STERILEPRODUCTS.CompoundingofsterileproductsmustconformtoWAC246871(ParenteralProductsfor
NonhospitalizedPatientsseeChapter2).
PharmacyCommissionGuidance.TheCommissionhasalsopublishedaguidanceonitswebsiteentitled
StandardsforPharmacist/PharmaciesCompoundingDrugProducts,whichlargelyreiterateWAC246878.336
AsofJanuary2017,noproposedrulesrelatingtocompoundingarelistedontheCommissionwebsite.
PRESCRIPTIONDRUGSAMPLES
ThePRESCRIPTIONDRUGMARKETINGACT(PDMA)placedrestrictionsonthedistributionofdrug
samplesbymanufacturers.Inessence,thelawrequiresthatsamplesoflegenddrugsbedistributedonlyto
authorizedprescriberspursuanttoarequestbythereceivingprescriber.Writtenrecordsmustberetainedby
manufacturersrepresentativesofthesamplestheyhavedistributed.
206
DISTRIBUTIONOFSAMPLESBYHOSPITALPHARMACIESORATDIRECTIONOFPRESCRIBER.Section503(d)(1)of
theactstatesthat,forpurposesofthissubsection,theterm"distribute"doesnotincludetheprovidingofa
drugsampletoapatientbyapractitionerlicensedtoprescribesuchdrug,byahealthcareprofessionalactingat
thedirectionandunderthesupervisionofsuchapractitioner,orthepharmacyofahospitalorofanother
healthcareentityactingatthedirectionofsuchapractitionerwhoreceivedthedrugsampleinaccordancewith
theactandregulations.
FDAGUIDANCEFORINDUSTRYONDISTRIBUTIONOFSAMPLESTOFREECLINICS.TheFDA
adoptedregulationsin1999toallowsamplestobedistributedtoacharitableorganization,whichisdefinedas
anonprofithospital,healthcareentity,organization,institution,foundation,association,orcorporationwhich
hasreceivedexemptionundersection501(c)(3)oftheInternalRevenueCode.Includedintheseproposed
regulationsweretherequirementsthatsuchsamplesmustbeinspectedbyalicensedpractitionerorregistered
pharmacist,anddrugsamplereceiptanddistributionrecordsmustbekeptbytheinstitutionforaminimumof3
years.(21CFR203.39)Numerousfreeclinicsassertedthattheseregulationswereoverlyburdensome,anda
studyofthemattercommissionedbytheFDAfoundthatclinicswithtotalrevenuesunder$200,000peryear
were,infact,overburdenedbytherules.Whileawaitingrulemakingtorevisetheregulations,theFDAadopted
aGuidanceforIndustry337onsamplesinfreeclinicsinMarch2006.TheguidanceindicatesthattheFDAwill
exerciseenforcementdiscretionwhenfreeclinicsarenotinfullcompliancewithsectionsoftheregulations
relatedtoreceipt,disposal,andrecordkeeping.
GUIDANCEREQUIREMENTSFORFREECLINICS.However,theclinicsareexpectedtocomplywithcertain
requirements,including
Thesamplemustbereceivedinitsoriginalunopenedcontainerwithintactlabeling.
Thesamplemaynotbedistributedoradministeredtoapatientunlessithasbeeninspectedbya
licensedpractitionerorregisteredpharmacisttoassureitisnotadulteratedormisbranded.TheFDAwill
allowregisteredpharmacistorlicensedpractitionertodesignateastaffmemberoftheclinictoperform
theinspection.
Theclinicmuststoresamplesproperlytoassuretheydonotbecomeadulteratedormisbranded.
TheclinicshallnotifytheFDAwithin5daysifitbecomesawareofknowntheftorsignificantlossofdrug
samplesfromtheclinic.
WASHINGTONRESTRICTIONSONSAMPLES.TheWashingtonstatutecorrespondingtofederallawis
RCW69.45.050:
Drugsamplesaredefinedasany...productsrequiringprescriptionsinthisstate,which[are]distributed
atnochargetoapractitionerbyamanufactureroramanufacturersrepresentative...
Drugsamplesmaybedistributedonlytoauthorizedprescribers,or,attheirrequest,toahospital
pharmacyorhealthcarefacility.
Thewrittenrequestshallcontain:
o Thenameandaddressofthereceivingpractitioner,andprofessionaldesignation.
o Name,strength,andquantityofsamplesdelivered.
o Nameofmanufacturerandindividualdeliveringthesamples.
o Datedsignatureofpractitionerrequestingthesample.
Nofeeorchargemaybeimposedfordistributionofsampleswithinthisstate.
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WILLIAME.FASSETT
Manufacturersrepresentativesmayonlypossesssampledrugsdistributedbythemanufacturerthey
represent.Thisdoesnotprecludeanyindividualfrompossessingdrugsamplesthathavebeen
prescribedforthatindividual.
LABELINGONSAMPLESDISPENSEDBYPRESCRIBERS.Asnotedearlierinthischapter,theLegendDrugAct
requiresthatpractitionerswhodispensesamplestopatientsmustlabelthesamplepackagewiththenameof
thepatientandthenameoftheprescriber.(RCW69.41.050(1))
ThePharmacyCommissionhaspromulgatedaparallelregulationinWAC246877020:
Thepossession,distribution,ordispensingoflegenddrugsamplesbyapharmacyisprohibited.
Thisdoesnotapplytoanypharmacyofalicensedhospitalorhealthcareentitywhichhasreceived
samplesbythedirectionofanauthorizedprescriberasspecifiedinRCW69.045.050.
Ahealthcareentityunderthisruleisonethatdoesnotincludearetailpharmacylicensedunderstate
law.
IMPACTOFRCW69.70.ItappearsnowthatRCW69.70,the2013statutedealingwithdonationsofdrugsand
distributionofdonateddrugsbycommunitypharmacies,hasoverturnedanygeneralprohibitiononthe
possessionofsamplesincommunitypharmacies.Thestatuteclearlyallowscommunitypharmaciestoreceive
donateddrugsuppliesfromdrugmanufacturers,anddoesnotexcludedrugsinpackagesmarkedsample.
Becausethesedrugsaredonatedtheyareclearlydistributedatnocharge.Thechapterincludesasection
statingthatnothinginthischapterrestrictstheuseofsamplesbyapractitionerduringthecourseofa
practitionersdutiesatamedicalfacilityorpharmacy.Aslongasthepharmacyisobtainingthesesamplesfor
distributionpursuanttoaprescriptioninaccordancewiththetermsofthestatute,thecommunitypharmacy
cannotbesummarilyprohibitedfrompossessingsamples.
Furthermore,pharmacistswithCDTAsarenowpractitionersunderthelegenddruglaw,andareentitledto
receivesamplesofdrugstheywouldbeauthorizedtoprescribeundertheCDTA.
Fortherequirementsrelatingtodonateddrugsincommunitypharmacies,seethediscussioninChapter3.
ACCOMMODATIONSALESANDTRANSFERSTOOTHER
PRACTITIONERS
ACCOMMODATIONSALES.Thereisalongtraditionofpharmacistsloaningorborrowingdrugsor
purchasingthemoutrightfromotherpharmaciststomeeturgentneeds.Theseexchangesareoftencalled
accommodationsales,andaregenerallyexcludedfromthedefinitionsofeitherwholesaleorretailsales.Asa
result,thesesalesortradesarenotsubjecttowholesaleorretailsalestaxes,ortobusinessandoccupation
taxes.
TRANSFERSTOOTHERPRACTITIONERS.Pharmacistsmayalsoselllegenddrugsdirectlytoauthorized
practitioners(seeTable43)foruseintheirpractices,butthosesalesaresubjecttoapplicabletaxes.Inaddition,
salestopharmacistsorotherpractitionersdonotrequirethepharmacistwhoisprovidingthedrugtoregisteras
awholesaleriftheydonotconstitutemorethan5%oftotalsalesasmeasuredduringany12consecutive
months(WAC246879010(10)(e)).However,thereceivingpractitionerisalsolimitedtonomorethan5%ofhis
orherpurchasescomingfromagivenpharmacy.
Pharmaciesmayalsoselllegenddrugstocertainotherindividualsforuseintheirpracticeoroccupation.The
followingisapartiallist,andotherindividualsmayassertarighttopurchaselegenddrugs,subjectto
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verification(e.g.,withthePharmacyCommission).AsnotedinChapter3,thePharmacyCommissionhas
recentlyemphasizedthattransferstootherpractitionersmustbetomeetanemergencyneed,andshouldnot
bearoutineonlyawholesalercanroutinelyselldrugstopractitioners.Ingeneral,theseoccasionalsalesare
recordedonaninvoice,notaprescription(seealsochapter5).
ANIMALCONTROLAGENCIESandhumanesocietiesmaypurchasedrugsinaccordancewithCommissionrules.338
MASTERSOFOCEANGOINGVESSELS(i.e.,shipcaptainsand/orfirstofficers)maypurchaselegenddrugsand
controlledsubstancestobeusedincaseofanemergency.Topurchasecontrolledsubstances,themastermust
appearinpersonatthepharmacy,andthepharmacymustmaintainarecordofSaleofControlledSubstances
toVessels.339ThereisnothingspecificintheFDCAaboutuseofprescriptiondrugsonvessels,buttheFDAonly
suggeststhatthepharmacistsupplyingprescriptiondrugsforuseonshipsshouldexercisereasonablecare
andassurethemselvesthattheprescriptiondrugsareinfactgoingtoashipsmedicinechestandarenotbeing
divertedtoimproperchannels.340
TEACHINGINSTITUTIONSmayregisterwiththeDEAtoorderandusecontrolledsubstancesinresearchand/or
instruction.Aseparateapplicationisusedforteachingandforresearch.Individualteachersdonotneedto
register,butusetheinstitutionsDEAnumberwhenorderingproducts,whichmaybesuppliedbyacommunity
pharmacyinaccordancewiththerulesfordistributiontootherregistrants.Theeducationalinstitution341and
individualresearchersmustalsoregisterwiththeBoardofPharmacy.(SeeChapter5).
REPACKAGINGISMISBRANDING.However,thelongacceptedpracticeofpharmacistsrepackagingor
relabelingdrugsthatareloaned,borrowed,orsoldtootherpractitionersisunacceptableundertheFDCAor
moststatelawsunlesstherepackagedproducthasalloftherequiredlabeling.Incompleterelabelingrenders
theproductmisbranded.
Inordertoavoidcreatingamisbrandedproduct,PHARMACISTSSHOULDLOAN,BORROW,SELL,ORTRADE
PRODUCTSWITHOTHERPHARMACIESORPRACTITIONERSONLYINTHEMANUFACTURERSORIGINALPACKAGE
WITHALLOFTHEACCOMPANYINGLABELING,INCLUDINGTHEPACKAGEINSERT.
Distributionoflegenddrugstootherpharmacistsorpractitionersmustbedocumentedinthepharmacys
records;thisisdonebypreparinganinvoiceandretainingacopy.(SeeChapter5forrequirementsrelatedto
salesofcontrolledsubstancestootherregistrants.)Pedigreesmayneedtobeprovidedforcertaintransfers(see
below).
Whenthedrugsinquestionarepurchasedataspecialprice(e.g.,byhospitals,orpharmacieseligiblefor340B
pricing),theymaynotberesoldtoanyentitythatisnoteligibleforthesamepricing.Todosoplacesthesellerin
possibleviolationoffederalantitrustlaws,or,inthecaseof340Bdrugs,federalfraudstatutes.Inemergencies,
thesedrugsmayonlybeloaned,andtheborrowermustrepaywiththesamequantityofthesamedrug
product.
DRUGSUPPLYCHAININTEGRITY
THEDRUGSUPPLYCHAINisgenerallythoughtofastheseriesofindividualsorfirmswhoengageinthe
distributionofadrugfromthepointofmanufactureoftheactivepharmaceuticalingredient(API)tothepointof
receiptofthefinisheddosageformbytheultimateuser.Itconsistsofacomplexarrayofchemical
manufacturers,drugproductmanufacturers,repackagers,wholesalers,pharmacies,hospitals,clinics,and
209
WILLIAME.FASSETT
reversedistributors.Particularlysince2004,therehasbeenincreasedconcernabouttheintegrityoftheUSdrug
supplychainandwaystoprotectitfromcounterfeit,subpotent,adulterated,orexpireddrugproducts.
THEPRESCRIPTIONDRUGMARKETINGACTOF1987wasoneofthefirstattemptstominimizethe
presenceofcounterfeitdrugsintheUS.Itwasamendedin1992bythePrescriptionDrugAct.Itrequiredinpart
thatcertainwholesalersorredistributorsprovideastatement,alsoknownasthedrugsPEDIGREE,priortoeach
wholesaledeliveryorsaleofprescriptiondrugs.TheActexcludesthedrugsmanufacturer,andauthorized
distributorsofrecord(ADR),fromthepedigreerequirement.Anauthorizeddistributormusthavean
ongoingrelationshipwiththemanufacturer.In1999,theFDApublishedproposedrulesdefiningongoing
relationship,butdelayedenforcementoftheserulesasaresultofconcernsraisedbyaffectedcompanies.In
2006,theseruleswerefinallyenforced,andtheFDApublishedaguidance,toanswerquestionsconcerning
theimplementationoftheserules.342Issuesofparticularinteresttopharmacistsinclude:
PharmacistsshouldbeabletofindlistofADRsforaparticularproductormanufactureronthemanufacturers
website.343
NonADRsmustsupplypedigreestophysiciansoffices.
Apharmacytransferringadrugtoanotherpharmacywillhavetoprovideapedigreeforthatdrugexceptfor
Intracompanytransfers
Transfersforadocumentedmedicalemergencytoanotherpharmacy
Saleofminimalquantitiesbyretailpharmaciestolicensedpractitionersforofficeuse
Chainpharmacywarehousesdonotneedtosupplyapedigreefortransferstoitsownretailoutlets
VERIFICATIONOFPEDIGREES.Pharmaciesarenotexpresslyrequiredtoverifytheaccuracyorauthenticityofa
pedigreeunderthePDMA,butaccordingtoFDA,theyareencouragedtoperformduediligenceinverifyingthe
accuracyoftheinformationandintegrityofthesourceofthedrugproduct.
RETENTIONOFPEDIGREES.Pedigreesmustberetainedbyallwholesaledistributorsinvolvedinthedistribution
ofthedrugproductfor3years.Ifthepharmacyreceivingthepedigreewillnotitselfengageinfurther
distributionoftheproducttopersonsotherthanaconsumerorapatient,thenthepharmacyisnotrequiredto
maintainthatpedigreeHowever,consistentwiththePDMA,FDAencouragespharmaciesandotherendusers
toretainthepedigreefor3years.
PEDIGREESWHENRETURNINGDRUGS.Pharmaciesandphysiciansofficesaretechnicallyrequiredtoprovidea
pedigreewhentheyreturndrugstoawholesaler.However,findingthatthiswouldbeveryhardforpharmacies
todo,particularlywhentheypurchasedthedrugfromanADRinthefirstplace,theFDAwillexercisediscretion
whenenforcingthisprovision:
Pharmaciesandphysiciansofficesmayreturndrugsthatareexpired,damaged,recalled,orinsome
othernonsalableconditionwithouthavingtoprovideapedigree,providingtheyreturnthedrugtothe
wholesalerormanufacturerfromwhomtheypurchasedthedrugs,ortoalicensedreversedistributor
fordestruction,andmaintainfor3yearsarecordthatdocumentseachreturnandthesourcefrom
which[they]originallypurchasedthedrugs.
Returnsfromhospitals,healthcareentities,andcharitableinstitutionsareexcludedfromthedefinitionof
wholesaledistribution,sotheywouldnotnormallyneedtoprovideapedigree.
210
SALEORPURCHASEOFAPHARMACY.Thepurchaseofapharmacybyanotherpharmacywouldnotbe
consideredwholesaledistribution,providedthatthedrugspurchasedbythesecondpharmacyaredispensedor
distributedbythatpharmacyinthenormalpracticeofretailpharmacy.However,pedigreesretainedbythe
firstpharmacyaspartofitsinventoryrecordsshouldbeprovidedandretainedfortheremainingretention
periodbythepurchasingpharmacy.
STATEPEDIGREELAWS.AsofJanuary2011,allbut20stateshadsomeformofdistributorlicensingstatute
withpedigreerequirementsthatwentbeyondtherequirementsofthePDMA.Thesestatelevelgreater
requirementswerepreemptedstartingin2015bytheDrugQualityandSecurityAct(seebelow).
STANDARDSANDTECHNOLOGIESFORIDENTIFYING,VALIDATING,AUTHENTICATING,
TRACKING,ANDTRACINGOFPRESCRIPTIONDRUGS.TheFDAAA(seeabove)requiresFDAto
developstandardsandvalidateeffectivetechnologiestosecurethedrugssupplychain.TheActrequiresthe
establishmentofastandardnumericalidentifier(SNI)tobeusedfortracingandidentifyingthedrug,aswellas
investigationoftechnologies,suchasradiofrequencyidentification(RFID)tohelptrackandvalidateadrugs
identity.
SERIALIZEDNATIONALDRUGCODE(SNDC).InMarch2010,FDApublishedaguidanceforindustry
indicatingthatthepackagelevelSNIformostprescriptiondrugsshouldbetheserializedNDC,consistingof
theNDCfollowedbyauniqueserialnumberforeachpackageofthedrug.344Theserialnumbercancontainup
to20characters.TheFDAbelievesthissNDCshouldbeinbothmachinereadableandhumanreadableformat.
Ultimately,pharmaciesshouldbeabletoscanansNDIandobtaininformationabouttheproductiondate,
expirationdate,andpriortransfersoftheindividualpackagefromanationaldatabase.
Certainprescriptiondrugs,suchabloodproducts,donotuseNDCs;theFDArecommendsuseofasystem
knownasISBT128fordeterminingtheSNIforthistypeofproduct.
DRUGQUALITYANDSECURITYACTOF2013.TitleIIoftheDQSAenactedtheDrugSupplyChain
SecurityActof2013,(DSCSA)whichputstheUSona10yeartracktodevelopafullyinteroperableelectronic
drugtrackandtracesystem.Thetrackandtracesystemwillultimatelyincorporatetheelements,suchasa
sNDC,describedaboveinthefinalsystem.Intheinterim,pharmaciesneedtomeetthefirstsetofdeadlines
thatapplytodispensers.345
DOCUMENTATIONOFDISTRIBUTEDDRUGSAUTHENTICITY.Startingin2014,3typesofdocumentation
regardingadrugproductbecameessentialtolawfuldistributionofthedrugfrommanufacturertowholesalerto
pharmacy:
TRANSACTIONHISTORYastatementinpaperorelectronicformthatincludesthetransactioninformationfor
eachpriortransactiongoingbacktothemanufactureroftheproduct.
TRANSACTIONINFORMATIONinformationconcerningtheproducttransferredduringagivensale,which
includes:
Theproprietyorestablishednameornamesofthedrug
Strengthanddosageform
NDCnumber
Containersize
Numberofcontainers
Lotnumberoftheproduct
211
WILLIAME.FASSETT
Dateoftransaction
Dateofshipment,ifmorethan24hoursafterthetransactiondate
Businessnameandaddressofthepersonfromwhomtheownershipisbeingtransferred
Businessnameandaddressofthepersontowhomownershipisbeingtransferred
TRANSACTIONSTATEMENTastatementinpaperorelectronicformthattheentitytransferringownershipina
transaction
IsauthorizedundertheDSCSA;
ReceivedtheproductfromapersonthatisauthorizedasrequiredundertheDSCSA;
Receivedtransactioninformationandatransactionstatementfromthepriorowneroftheproduct;
Didnotknowinglyshipasuspectorillegitimateproduct;
Hadsystemsandprocessesinplacetocomplywithverificationrequirementsunder582;
Didnotknowinglyprovidefalsetransactioninformation;and
Didnotknowinglyalterthetransactionhistory
PHARMACIESRESPONSIBILITIES.Dispensers(pharmacies)mustfulfillthefollowingresponsibilities,whichapply
tohospitals,chainpharmacies,independentpharmacies,andotherdispensers:
Dispensersmaynotacceptownershipofaproductunlessthepriorownerprovidesatransaction
history,transactioninformation,andatransactionstatement.
Dispensersmustmaintaintransactionhistories,information,andstatementsfor6yearsasnecessaryto
investigateasuspectproduct.
Dispenserstransferringproductstootherownersmustprovideatransactionhistory,informationand
statementtothesubsequentowner,exceptfor:
o Returnsofasaleableproducttoatradingpartnerfromwhomitwasobtained
o Returnsofanonsaleableproducttoamanufacturer,wholesaler,orreturnsprocessor
o Dispensingtoapatient
o Accommodationsalestootherpharmaciesorphysicians
Dispensersmusthaveinplacesystemstoquarantine,investigateandnotifytheSecretaryofcleared
suspectproducts.
Dispensersmusthaveameansforassistinginthedisposalandanalysisofillegitimateproductsandfor
notificationswithin24hourstotheSecretaryandtradingpartnersofdiscoveryofillegitimateproducts.
NotificationstoFDAaremadeusingForm3911;findablebyGooglingFDAForm3911.
TIMELINEIN2017ANDAFTER.FutureeventsintheDSCSAimplementationtimelinethataffectpharmacies
willincludethefollowing:
2017A2dimensional(2D)barcodewiththeuniqueserializedNDCwillberequiredoneachdrug
package.Pharmacieswillbeable(butnotrequired)tocheckthesenumbersandverifytheproducts
authenticity.
2020Pharmacieswillonlybeallowedtopurchasebarcoded,serializedproducts,andmustverifythe
serialnumbersofacertainpercentageofsuspectmedicineswhenconductinginvestigationsinto
productsthatappearpotentiallycompromisedorunsafe.
2023PharmaciesmustparticipateinafullyelectronictraceabilitysystemthatusestheserializedNDCs
tohelpdetectillegitimateproducts.
212
IMPORTATIONOFDRUGSFROMOUTSIDEOFTHEUNITEDSTATES
Becauseothercountries,particularlyCanada,haveregulatorysystemsthatcontrolthepriceschargedfor
prescriptiondrugs,andforothermarketingreasons,USmadebrandnamedrugssellforlessoutsideofthe
UnitedStatesthanthesameproductsdointheUS.Manufacturerscitemanyreasonsforthis,nottheleastof
whichincludestheregulatorycostsassociatedwithmarketingdrugsintheUS,aswellasotherfacetsoftheUS
economicsystemthatjustifydifferentpricingstrategies.Criticsofthecostofdrugshavesuggestedafairly
simplesolution:allowUScitizenstopurchasedrugsfromothercountriesatthelowerprices.Practical
objectionstothisproposalincluderealquestionsabouttheabilityofasmallnationlikeCanadatobeableto
meettheneedsoftheUS,andabouttheabilityoftheUStoregulatedrugsthatmaybeshippedfromCanada,
forexample,asawaystationfromChinaorothersources.
FDCAPROHIBITIONSONIMPORTATION.Atanyrate,themajorcurrentimpedimenttotheplanisthe
Food,Drug,andCosmeticAct,whichpreventssuchimportation.TheFDAhascited3majorlegalandregulatory
basesfordenyingtheimportationofdrugsfromothercountries:
NODRUGMAYBEIMPORTEDINTOTHEUSEXCEPTBYAFIRMREGISTEREDWITHTHEFDA,andtheparticular
drugproductmustbeanapproveddrugwithacurrentNDA.
ONLYUSLICENSEDDRUGFIRMSMAYREIMPORTUSMADEFDAAPPROVEDDRUGSintotheUSformarketing
anddistributionwithintheUS(21U.S.C.381(d)(1)).
DRUGSIMPORTEDFROMOUTSIDETHEUSMAYALSOVIOLATETHEFDCAFOROTHERREASONS.Theymaybe:
Unapproved(21U.S.C.355)
Labeledincorrectly(21U.S.C.353(b)(2)),and/or
Dispensedwithoutavalidprescription(21U.S.C.353(b)(1))
PERSONALTRANSPORTOFPRESCRIBEDDRUGS.TheFDAhasadoptedasaregulatorypolicy346thatit
willnotgenerallytakeactionagainstindividualswhobringsmallamountsofdrugs(generallynotmorethana3
monthsupply)intotheUSfromabroad(especiallyCanada)forTHEIRPERSONALUSEASPRESCRIBEDBYTHEIR
PERSONALPHYSICIAN.Thisdoesnotmeanthatsuchactionsarelegal,onlythattheFDAwillusediscretionin
enforcingtheActunderthecircumstancessetforthinitspolicy.
NOPERSONALTRANSPORTOFCONTROLLEDSUBSTANCES.NeithertheFDAnortheDEAwillknowinglypermit
importationofCONTROLLEDSUBSTANCESbyindividualsfortheirownuse.
Congresspassedlegislationin2002(theMedicineEquityandDrugSafety(MEDS)Act),whichwasrevisedin
2003bytheMedicarePrescriptionDrug,ImprovementandModernizationAct(MMA)thatmodifiedtheFDCAto
potentiallyallowforreimportationofUSmadeFDAapproveddrugsfromCanadabypharmacists,wholesalers,
andindividuals.ThisONLYBECOMESEFFECTIVEFOLLOWINGACERTIFICATIONfromtheSecretaryofHealthand
HumanServicesthatimplementationoftheseprogramswould(1)posenoadditionalrisktopublichealthand
safety,and(2)resultinasignificantreductioninthecostofdrugstotheAmericanconsumer(21USC384).An
HHSTaskForceonDrugImportationissuedareporttoCongress(requiredbytheMMA)inDecember2004that
essentiallyconcludedthatreimportationwouldposesignificantrisksandwouldnotresultinacorrespondingly
significantreductionindrugcoststoAmericanconsumers.TwoHHSSecretarieshavedeclinedtoprovidethe
certificationprovidedforbyeithertheMEDSActortheMMA.
213
WILLIAME.FASSETT
DEPARTMENTOFHOMELANDSECURITYPROHIBITEDFROMPREVENTINGINDIVIDUALSFROMBRINGINGIN90
DAYPERSONALSUPPLIESOFDRUGSFROMCANADA.Congressin2006adopted535oftheHomelandSecurity
AppropriationsAct(PL109295)whichprovidesthatUSCustomsandBorderProtectionmaynotuse
appropriatedfundsforthepurposeofpreventingindividualpatientsfrombringinguptoa90daypersonal
supplyofFDAapproveddrugsintotheUSfromCanada.Thisprovisiondoesnotapplytobiologicalproductsor
controlledsubstances.
STATEWAIVERREQUESTS.NumerousstateandlocalgovernmentshaverequestedwaiversfromtheFDA
toallowvariousschemesforimportingdrugsfromCanada.TheFDAhasroutinelydeniedthesewaiverrequests
fromawidevarietyofstatesincludingOregon,California,Nevada,Texas,Minnesota,Illinois,NewHampshire,
andWisconsin.OfparticularinterestisthedenialoftherequestforawaiverfromMontgomeryCounty,
Maryland,thecountyinwhichtheFDAsHeadquartersislocated.
A2004requestfromVermontwasdeniedbytheFDA,andVermontfiledsuittocompelapprovaloftheirrequest.In
September2005,thefederaldistrictcourtfortheDistrictofVermontdismissedtheVermontlawsuitandaffirmedthe
FDAspositionthat,asamatteroflaw,grantingthewaiverisprohibitedbytheFDCA.(StateofVermontv.Leavitt,405F.
Supp.2d466(D.Vt.,2005)).
WASHINGTONIMPORTATIONWAIVERREQUEST.TheWashingtonrequestforawaivertoallowforthelicensing
ofCanadianpharmaciesasNonresidentPharmaciesinWashington,andforthelicensingofCanadian
wholesalers,wasdeniedbyFDAonMarch17,2006.
MAINESTATUTE.In2013theStateofMainepassedlegislationthatremovedrestrictionsinthestates
pharmacypracticeactagainstsalesofdrugsfromoutsidetheUStoMainecitizensbyforeignpharmacies,and
foreignpharmaciesareshippingdrugsintothestateunderthelaw.Accordingtopressreports,shipmentsare
comingnotonlyfromCanadaandGreatBritain,butfromothernationsaswellmostlyviaInternetsales.The
statuteisbeingchallengedinstatecourt,butithasstimulatedintroductionoflegislationinCongresstomodify
theFDCAtoallowimportationunderstatelaws.
InJanuary2015,theFDAbeganrefusingshipmentsofprescriptiondrugsintoMainefromGreatBritain,and,
whileitdoesnttypicallytakeactionagainstindividuals,itcantakeactionagainstcompaniessuchasFedExor
UPStorequirethemtoembargoshipmentsuntiltheFDAhasclearedthem.Apressreportdescribedhowa
MainecitizenpaidfordrugsfromGreatBritain,onlytohavethemdeniedentrybytheFDA.347
InFebruary2015,afederaldistrictcourtjudgestruckdowntheMainestatuteasbeingpreemptedbythe
requirementsoftheFDCA.348
214
Appendix4A:ExampleRequestforNonChildResistantContainer
RequesttoDispensePrescriptionMedicationinNonchildresistantContainerandRelease,HoldHarmless
andAgreementtoIndemnify
I understand that all prescription medications are required to be dispensed in a child-resistant container
unless the patient or the patient's agent authorizes the pharmacist to dispense the medication in a regular (non-
child-resistant) container.
I certify that I am the patient or the patient's authorized representative and agent and that I request that all
medications, now and in the future, for the below-named patient be dispensed in a non-child-resistant container.
I understand that prescription medications may be dangerous, especially to children, and that use of
a regular (non-child-resistant) container increases the risk that a child may gain access to the medicine
in the container. I understand that this may cause serious injury or even death to a child or other person gaining
access to this medication.
I acknowledge that the pharmacist and the pharmacy have offered to provide additional training to me or
the patient on how to use child-resistant containers, and have offered to provide alternative types of containers
at a nominal fee that will are designed for persons with arthritis or other conditions to make them easier to
open.
I hereby release the pharmacist and the pharmacy from all liability which may be caused by the lack of a
child-resistant container for any medications for the below-named patient.
I hereby agree to hold harmless and indemnify the pharmacy and its agents and pharmacists from any loss
or damage to any and all third parties, including children and their relatives, which may result, in whole or in
part, from the lack of a child-resistant container for any medications for the below-named patient which have
been dispensed in a regular (non-child-resistant) container as authorized and requested in this Release, Hold
Harmless and Agreement to Indemnify.
Dated this ______________day of ________20_____.
Patient
Authorized Agent of Patient
(Adapted by William E. Fassett, Ph.D., R.Ph., for instructional purposes only, from a form developed by Craig A. Ritchie,
R.Ph., J.D., Sequim, WA. No recommendation is made respecting the use of this form, nor is any warranty of its fitness
for a particular situation made, express or implied. All responsibility for the utility or applicability of this form is expressly
disclaimed. Pharmacists should consult an attorney for advice on the applicability of this or any other form to their
particular circumstances.)
215
WILLIAME.FASSETT
Appendix4B:SampleCompoundingWorkupForm
ABCPharmacy
ExtemporaneouslyCompoundedDosageForms
PatientCareWorkup
Patient: DOB: SSN:
Address: Gender: Carrier:

Phone: Formula# Plan:
Prescriber: AssociatedRx#
Allergies:
MedicalConditions:
Prescriberagreementtouseacompoundedalternativetothemarketedproductwas
obtainedbythepharmacistinconsultationwiththeprescriberon____/____/____
indicatedontheprescriptionnotapplicablePharmacistInitials:________
Problem Objective Indicators
1.
2.
Marketedproductalternative:
Reasonwhymarketedproductisundesirable:
Extemporaneouslycompoundedalternative:
Rationaleforuseorevidenceofeffectiveness:
PlannedFollowUp
Date Comments NextFollowUp
PatientCertification
Iunderstandthattheextemporaneouslycompoundedalternativeindicatedaboveistobepreparedspecificallyformyuse
tomeetmymedicalneedsasdeterminedbymeandmyprescriber.Ihavereceivedinformationfrommyprescriberand
pharmacistconcerningthepurposeandeffectsofthisproduct.IunderstandthatitisnotanFDAapproveddosageform.I
haverequestedthisproductbecauseIbelieveitrepresentsthebestalternativetomeatthepresenttime.
PatientSignature Date_______________
Note:Thisexampleisforinstructionalpurposesonly.Thisshouldbereviewedwithanattorneytodeterminethe
applicabilitytoanyparticularsetting.
216
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