Rennebohm Hall nUniversity of Wisconsin-Madison School of Pharmacy 777 Highland Avenue nMadison, WI 53705-2222n608.262.5378naihp@aihp.org

ThisslidepresentationwascompiledandproducedbyRobertMcCarthy,Ph.D.,ProfessorandDeanEmeritusattheUniversityofConnecticutSchoolofPharmacyforhisclass“TheHistoryofAmericanPharmacy.”Prof.McCarthycreatedthisversionoftheslidetalkforhisclassintheSpringof2016.ThisslidepresentationwasdownloadedfromtheTeachingtheHistoryofPharmacysectionofthewebsiteoftheAmericanInstituteoftheHistoryofPharmacy(https://aihp.org/historical-resources/teaching-the-history-of-pharmacy/)whereacopyofthesyllabus(.pdf)forProf.McCarthy’sclassisalsoavailable.This.pdfcopyoftheslidepresentationwassharedwiththepermissionofProf.RobertMcCarthyforthepersonalandeducationaluseofinterestedreaders.

PHRX4001W-002TheHistoryofAmericanPharmacySpring2016

EVOLUTIONOFTHEPHARMACOPOEIA

AnAmericanPharmacopeia•  1808:TheMassachusettsPharmacopoeiaispublishedprovidingastateguidetodrugstandards.•  TheMassachusettsPharmacopoeiawasusedbyapothecariestoproperlyfillprescriptionsfromphysicianssinceitdefinedtheidentityofdrugsandpreparations.

•  1820:TheU.S.PharmacopeialConventionfoundedinWashington,DC;althoughallstatemedicalsocietieswereinvitedtosenddelegates,only11statesattended;onlyabout200drugswereincludedinthefirstUSPsincetheyweretheonlyonesdeemed“mostfullyestablishedandbestunderstood.”

UnitedStatesPharmacopoeia(USP)•  1830:ThefirstrevisionoftheUSPpublished;revisionscontinueatanintervalofevery10years.•  1848:CongresspasseslegislationmakingtheUSPanofficialcompendium.•  1888:FirstNationalFormulary(NF)publishedbytheAmericanPharmaceutical(nowPharmacists)Association.•  1900:USPConventionandBoardofTrusteescreated.•  1906:USPandNFstandardsforstrength,quality,andpurityrecognizedasofficial.

UnitedStatesPharmacopoeia(USP)•  1938:USPandNFstandardsforstrength,quality,purity,packaging,andlabelingrecognizedasofficialandenforcedbyFDA;"NewDrug"conceptestablished;FDAapprovesdrugsforsafetybeforemarketing.•  1942:USPrevisioncyclechangedtoevery5years.•  1971:USPmovesheadquarterstoRockville,MD.•  1975:USPacquiresNFfromAPhA.•  1977:USPandNFscoperedefined:USPspecifiesstandardsfordrugsubstancesanddosageforms;NFspecifiesstandardsforexcipients.•  1980:USPandNFpublishedundersamecover;USPDispensingInformation(USPDI)published.•  1993:FederalOmnibusBudgetReconciliationActs(OBRA'90and'93)nameUSPDIassourceofinformationthatstateMedicaidagenciescanusefordrugutilizationreview,patientcounseling,andmedicallyacceptedoff-labelusesofmedicines.

UnitedStatesPharmacopoeia(USP)•  1994:USPsignsanagreementwiththeAmericanMedicalAssociationtocombinetheinformationinAMA'sDrugEvaluationsdatabasewiththeUSPDIdatabasetodevelopasingleproductthatcontainsdrugandtherapeuticinformation.• 2002:USP-NFpublishedannually.• 2000s:USPdevelopsoffices/laboratoriesaroundtheworldandcollaborateswiththepharmacopoeiasofothernationsindevelopingdrugstandards.

Source:USPWebSite

NationalFormulary•  1883:NYPharmacistSamuelBendinerandNYhospitalpharmacistCharlesRiceledanefforttomodernizetheUSPharmacopoeia;BendinerinspiredthecreationoftheNewYorkandBrooklynFormulary(NYBF);RicenegotiatedanagreementtosharetheinformationintheNYBFtodevelopanationalformulary,whichitwashopedwouldbeusedbyphysiciansinprescribingratherthanrecommendingtheuseofproprietarymedicines.•  1886:APhApublishedapreliminarydraftoftheNationalFormularyofUnofficinalPreparations,askingforfeedbackfromthepharmacyprofession.•  1888:TheNationalFormulary(NF)ispublishedforthefirsttimebyAPhA.•  1906:ThesecondrevisionoftheNFcoincideswiththepassageoftheFood&DrugAct,whichnamedtheNFasoneoftheofficialstandardsforpharmaceuticals,muchtothesurpriseofAPhA.

NationalFormulary(NF)•  ThefirstthreeeditionsoftheNFprovidedpracticingpharmacistswithformulasforsmallscalecompounding,allowingforcompetitionwithready-madepreparations.•  1916:NationalFormularyIVset“definitestandards.”•  1935:TheNFestablishedadrugstandardslabattheUniversityofIllinoisCollegeofPharmacy.•  1938:APhAestablishedtheDrugStandardsLaboratoryinWashington,DC.;duringthe1960s,thislabwasrevitalizedthroughfinancialsupportfromUSP(whichwasusingthislab’sservices)andtheAMA.•  In1960,therewerediscussionofmergingtheNFandUSP;by1966,formaldiscussionofamergerwasunderway.•  1975:USPpurchasedboththeNFandDrugStandardsLaboratoryfromAPhA.•  1998:USPlicensedUSPDItoTheThomsonCompany;USPDIispublishedbytheirMicromedexsubsidiary.

USPToday•  “USPisauniqueorganizationwhoseactivitiesaredirectedbythreegoverningbodiescomposedofmorethan900volunteersandwhoseday-to-dayoperationsaremanagedbyanexecutiveteamandstaffofmorethan800employees.”•  “Governance:USPisgovernedbytheConventionmembership,theBoardofTrustees,andtheCouncilofExpertsanditsExpertCommittees.Thesedecision-makingbodiesguideUSP’sactivitiesinthebestinterestofqualitypublichealth.”•  “ExecutiveTeam:USP’sexecutiveteamhelpsmanageallUSPoperationsatitsfiveinternationallocationsinsupportofthegoverningbodies’standards-settingactivities.USPstaffprovidesupportforvolunteerandmemberactivities,scientifictesting,qualityassurance,standardsacquisition,verificationservices,trainingindevelopingregions,educationprograms,customerservice,harmonization,andoutreachandcommunicationsefforts.”

Source:USPWebSite.

TheUnitedStatesPharmacopeiaandtheNationalFormulary(USP–NF)FoodChemicalsCodexUSPDietarySupplementsCompendiumUSPMedicinesCompendium(MC)ReferenceStandardsOtherResources–PharmacopeialForum–FCCForum–USPDictionary–ChromatographicColumns

USP’sCompendialActivities

USPToday

USPToday•  UnitedStatesPharmacopeia38-NationalFormulary33•  PublishedNovember1,2014;officialMay1,2015

•  Supplement1totheUnitedStatesPharmacopeia38-NationalFormulary33•  PublishedFebruary1,2015;officialAugust1,2015

•  Supplement2totheUnitedStatesPharmacopeia38-NationalFormulary33•  PublishedJune1,2015;officialDecember1,2015