Rennebohm Hall nUniversity of Wisconsin-Madison School of Pharmacy 777 Highland Avenue nMadison, WI [email protected]
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
