本文件由AI本文件由AI進(jìn)行翻譯，僅供行業(yè)交流使用，譯文準(zhǔn)確性不做最終負(fù)責(zé)，僅供參考GENERALNOTICESANDREQUIREMENTS凡例和要求ApplyingtoStandards,Tests,Assays,andOtherSpecificationsoftheUnitedStatesPharmacopeia適用于《美國藥典》的標(biāo)準(zhǔn)、測試、化驗(yàn)和其他規(guī)范TheGeneralNoticesandRequirementssection(theGeneralNotices)presentsthebasicassumptions,definitions,anddefaultconditionsfortheinterpretationandapplicationoftheUnitedStatesPharmacopeia(USP)andtheNationalFormulary(NF).(凡例)給出對USP和NF中假設(shè)、定義、默認(rèn)條件的解釋和應(yīng)用。RequirementsstatedintheseGeneralNoticesapplytoallarticlesrecognizedintheUSPandNF(the“compendia”)andtoallgeneralchaptersunlessspecificallystatedotherwise.USPNF（《藥典》）認(rèn)可的所有全部專論和全部通則。TITLEANDREVISION標(biāo)題和版本ThefulltitleofthisjointcompendiumisThePharmacopeiaoftheUnitedStatesofAmericaandtheNationalFormulary(USP–NF).AlthoughUSPandNFarepublishedtogetherandsharetheseGeneralNotices,theyareseparatecompendia.Wheretheterms“USP”,“NF”,or“USP–NF”areusedwithoutfurtherqualification,theyrefertothecurrentlyofficialstandard.USP–NF全稱是《美利堅(jiān)合眾國藥典》和《國家處方集》。盡管USP和NF一起出版并共享這些凡例，"USP"、"NF"USP-NF等術(shù)語而未作進(jìn)一步限定時(shí)，均指當(dāng)前的法定標(biāo)準(zhǔn)。NewandrevisedcontentisaddedtotheUSP–NFperiodically(seesection2.10OfficialText).Routinerevisionsarepublishedthreetimesayear,onthefollowingdates,correspondingwiththree“issues”:USP-NF定期添加新內(nèi)容和修訂內(nèi)容（2.10節(jié)正式文本）。常規(guī)修訂每年出版三次，日期如下，對應(yīng)"issues"：USP–NF2021Issue1:PublishedNovember1,USP-NF20211期：111日出版、2020USP–NF2021Issue2:PublishedFebruary1,2020USP-NF20212期：2月1日出版、2021USP–NF2021Issue3:PublishedJune1,20212021USP-NF20213期：20216月1日出版“Issues”representdatesonwhichnewandrevisedcontentisaddedtotheUSP–NF.TheUSP–NFisincontinuousrevision,withstandardshavingofficialdatesthatcorrespondtotheirspecificrevisionhistories."Issues"代表USP-NF添加新內(nèi)容和修訂內(nèi)容的日期。USP-NF不斷修訂，標(biāo)準(zhǔn)的正式日期與其具體的修訂歷史相對應(yīng)。Changetoread:改為OFFICIAL STATUS AND RECOGNITION官方地位和法律承認(rèn)2.10OfficialText正式文本OfficialtextoftheUSPandNFispublishedonlineathttps://.USPNF的正式文本在https://上在線發(fā)布。RoutinerevisionsarepublishedintheUSP–NFandbecomeofficialonthedateindicated,usuallysixmonthsafterpublication.USP-NF中公布，并在所示日期（通常是公布后六個(gè)月）成為正式版本。AcceleratedRevisions,publishedperiodicallyintheUSP–NF,aredesignedtomakerevisionsofficialmorequicklythanthroughtheroutineprocessforpublishingstandardsintheUSP–NF.AcceleratedRevisionsmayalsobepublishedontheOfficialTextsectionofUSP’swebsite(ww/official-text).AcceleratedRevisionssupersedepreviouslypublishedcontentandbecomeofficialonthedateindicated.USP-NFUSP-NF中出版標(biāo)準(zhǔn)的常規(guī)程序更快的速度使修訂成為正USP(ww/official-text)的正式文本部分發(fā)布。加速修訂版取代之前發(fā)布的內(nèi)容，并在所示日期成為正式版本。InterimRevisionAnnouncementsareAcceleratedRevisionstoUSPandNFthatcontainrevisionsandtheirofficialdates.USPNF的加速修訂版，其中包含修訂內(nèi)容及其正式日期。RevisionBulletinsareAcceleratedRevisionstoofficialtextorpostponementsthatrequireexpeditedpublication.TheygenerallyareofficialimmediatelyunlessotherwisespecifiedintheRevisionBulletin.修訂公告是對正式文本的加速修訂或需要快速發(fā)布的延期公告。除非修訂公告中另有說明，否則它們通常立即成為正式文本。ErrataareAcceleratedRevisionsrepresentingcorrectionstoitemserroneouslypublished.勘誤表是加速修訂本，是對錯(cuò)誤出版的項(xiàng)目所作的更正。Periodically,anon-officialvolumeofassociatedrevisionsandadditionstotheUSP–NFispublishedinprintorothermedia.Thisvolumeisintendedtoserveasahistoricalreferencedocumentandisnotconsideredofficialtext.USP-NF的相關(guān)修訂和增補(bǔ)內(nèi)容會定期以印刷品或其他媒體形式出版非官方版本。本卷旨在作為歷史參考文件，不被視為正式文本。2.20OfficialArticles法定產(chǎn)品AnofficialarticleisanarticlethatisrecognizedinUSPorNF.Anarticleisdeemedtoberecognizedandincludedinacompendiumwhenamonographforthearticleispublishedinthecompendiumandanofficialdateisgenerallyorspecificallyassignedtothemonograph.法定產(chǎn)品是USP或NF認(rèn)可的產(chǎn)品。當(dāng)某一產(chǎn)品的專論在藥典中出版，且該專論一般或特別指定了正式日期時(shí)，該產(chǎn)品即被視為得到認(rèn)可并被納入藥典。Thetitlespecifiedinamonographistheofficialtitleforsucharticle.Othernamesconsideredtobesynonymsoftheofficialtitlesmaynotbeusedassubstitutesforofficialtitles.▲ForabiologicproductlicensedunderthePublicHealthServiceAct,theofficialtitleshallbethetitlespecifiedintherelevantmonographplusanyprefixand/orsuffixdesignatedbytheFDAunlessotherwisespecifiedintheapplicablemonograph.▲(USP1-Dec-2022)Fordrugproductsthatincorporateasensortodetectthattheproducthasbeenadministered,theofficialtitleshallbethetitlespecifiedintherelevantdrugproductmonographplusthewords“withsensor”.專論中指定的標(biāo)題是該文章的正式標(biāo)題。不得使用被視為正式名稱同義詞的其他名稱替代正式名稱。對于根據(jù)公共衛(wèi)生服務(wù)法獲得許可的生物制品，正式名稱應(yīng)為相關(guān)專論中規(guī)定的名稱加上FDA指定的任何前綴和/或后綴，除非適用專論中另有規(guī)定。(USP1-Dec-2022)對于裝有傳感器以檢測產(chǎn)品是否已給藥的藥品，正式名稱應(yīng)為相關(guān)藥品專論中規(guī)定的名稱加上""字樣。Officialarticlesincludebothofficialsubstancesandofficialproducts.Anofficialsubstanceisadrugsubstance,excipient,dietaryingredient,otheringredient,orcomponentofafinisheddeviceforwhichthemonographtitleincludesnoindicationofthenatureofthefinishedform.法定產(chǎn)品包括法定物質(zhì)和法定產(chǎn)品。法定物質(zhì)是一種原料藥、輔料、膳食成分、其他成分或成品器械的組成部分，其專論標(biāo)題不包括成品形式性質(zhì)的說明。2.30LegalRecognition法律認(rèn)可TheUSPandNFarerecognizedinthelawsandregulationsofmanycountriesthroughouttheworld.RegulatoryauthoritiesmayenforcethestandardspresentedintheUSPandNF,butbecauserecognitionoftheUSPandNFmayvarybycountry,usersshouldunderstandapplicablelawsandregulations.IntheUnitedStatesundertheFederalFood,Drug,andCosmeticAct(FDCA),bothUSPandNFarerecognizedasofficialcompendia.AdrugwithanamerecognizedinUSP–NFmustcomplywithcompendialidentitystandardsorbedeemedadulterated,misbranded,orboth.See,e.g.,FDCA§501(b)and502(e)(3)(b);alsoU.S.FoodandDrugAdministration(FDA)regulations,21CFR§299.5(a&b).Toavoidbeingdeemedadulterated,suchdrugsmustalsocomplywithcompendialstandardsforstrength,quality,andpurity,unlesslabeledtoshowallrespectsinwhichthedrugdiffers.See,e.g.,FDCA§501(b)and21CFR§299.5(c).Inaddition,toavoidbeingdeemedmisbranded,drugsrecognizedinUSP–NFmustalsobepackagedandlabeledincompliancewithcompendialstandards.SeeFDCA§502(g).USPNFUSPNF中提出的標(biāo)準(zhǔn)，但由于各國對USP和NF的認(rèn)可程度可能不同，用戶應(yīng)了解適用的法律和法規(guī)。在美國，根據(jù)聯(lián)邦食品(FDCA)，USPNF都被認(rèn)定為官方藥典。USP-NF認(rèn)可的藥品名稱必須符合藥典身FDCA§501(b)502(e)(3)(b)；另見美(FDA)法規(guī)，21CFR§299.5(a&b)。為避免被視為摻假，此類藥品還必須符合藥典規(guī)FDCA§501(b)21CFR§299.5(c)502(g)。AdietarysupplementrepresentedasconformingtospecificationsinUSPwillbedeemedamisbrandedfoodifitfailstosoconform.SeeFDCA§403(s)(2)(D).FDCA§403(s)(2)(D)。EnforcementofUSPstandardsistheresponsibilityofFDAandothergovernmentauthoritiesintheU.S.andelsewhere.USPhasnoroleinenforcement.USPFDA和其他政府機(jī)構(gòu)負(fù)責(zé)。USP不參與執(zhí)行工作。CONFORMANCETOSTANDARDS符合標(biāo)準(zhǔn)3.10ApplicabilityofStandards標(biāo)準(zhǔn)的適用性Standardsforanarticlerecognizedinthecompendia(USP–NF)areexpressedinthearticle’smonograph,applicablegeneralchapters,andGeneralNotices.Theidentity,strength,quality,andpurityofanarticlearedeterminedbytheofficialtests,procedures,andacceptancecriteria,andotherrequirementsincorporatedinthemonograph,inapplicablegeneralchapters,orintheGeneralNotices.藥典(USP-NF)認(rèn)可的產(chǎn)品標(biāo)準(zhǔn)在產(chǎn)品的專論、適用的通則和凡例中表述。產(chǎn)品的特性、強(qiáng)度、質(zhì)量和純度由官方測試、程序和可接受標(biāo)準(zhǔn)以及專論、不適用的通則章節(jié)或一般公告中包含的其他要求決定。Inamonograph,requirementsforofficialarticlesareindicatedintwoways:(1)forcertainmonographs,aftertheofficialtitle,theprimarilyinformationalportionsofthetextappearfirst,followedbythetextcomprisingrequirements,thelattersectionofthemonographbeingintroducedbyadoublearrowsymbol?;and(2)formonographsmorerecentlyredesigned,requirementsappearintheofficialtitleandinanytextbeginningwiththesectiontitled“Definition”.Ineitherformat,informationthatappears:(1)afterthetitlebutbeforethedoublearrowsymbol;(2)afterthetitlebutbeforethesectiontitled“Definition”;or(3)inorafterthesectiontitled“AuxiliaryInformation”isprovidedforinformationalpurposes.SeePrefaceforinformationrelatedtoupdatestoChemicalInformation.)的主要信息部分，然后是包含要求的正文，專論的后一部分用雙箭頭符號?表示；(2)對于最近重新設(shè)計(jì)位置的信息僅供參考：(1)標(biāo)題之后，雙箭頭符號之前；(2)標(biāo)題之后，"定義"部分之前；或(3)"輔助信"部分中或之后。有關(guān)""更新的信息，請參見"前言"。WhereconformancetoanyspecificationsrepresentedbyChemicalInformationiscriticaltoestablishingidentity,purity,potency,oranotherqualityattributeofanofficialarticle,themonographwillincludesuchspecificationsinthetextthatstatesrequirements.論將在說明要求的文本中包括這些規(guī)格?！癆pplicablegeneralchapters”meansgeneralchaptersnumberedbelow1000orabove2000thataremadeapplicabletoanarticlethroughreferenceinGeneralNotices,amonograph,oranotherapplicablegeneralchapternumberedbelow1000.WheretherequirementsofamonographdifferfromtherequirementsspecifiedintheseGeneralNoticesoranapplicablegeneralchapter,themonographrequirementsapplyandsupersedetherequirementsoftheGeneralNoticesorapplicablegeneralchapters,whetherornotthemonographexplicitlystatesthedifference."適用的通則"是指編號低于1000或高于2000的通則，這些章節(jié)通過凡例、專論或編號低于1000的另一適用的通則的提及而適用于某一產(chǎn)品。如果專論的要求與凡例或通則中規(guī)定的要求不同時(shí)，則專論的要求適用并取代凡例或通則的要求，無論專論是否明確說明了兩者的區(qū)別。Generalchaptersnumbered1000to1999areforinformationalpurposesonly.Theycontainnomandatorytests,assays,orotherrequirementsapplicabletoanyofficialarticle,regardlessofcitationinageneralchapternumberedbelow1000,amonograph,ortheseGeneralNotices.Generalchaptersnumberedabove2000applyonlytoarticlesthatareintendedforuseasdietaryingredientsanddietarysupplements.GeneralchaptercitationsinNFmonographsrefertoUSPgeneralchapters.編號為1000至1999的總章僅供參考。它們不包含適用于任何法定產(chǎn)品的強(qiáng)制性試驗(yàn)、化驗(yàn)或其他要求，無論編號低于1000的總章、專論或凡例中如何引用。編號高于2000的總章僅適用于用作膳食成分和膳食補(bǔ)充劑的產(chǎn)品。NFUSP通則。EarlyadoptionofrevisedstandardsinadvanceoftheofficialdateisallowedbyUSPunlessspecifiedotherwiseatthetimeofpublication.Whererevisedstandardsforanexistingarticlehavebeenpublishedasfinalapproved“officialtext”(asapprovedinsection2.10OfficialText)buthavenotyetreachedtheofficialdate(6monthsafterpublication,unlessotherwisespecified;see“officialdate”,section2.20OfficialArticles),compliancewiththerevisedstandardshallnotprecludeafindingorindicationofconformancewithcompendialstandards,unlessUSPspecifiesotherwisebyprohibitingearlyadoptioninaparticularstandard.USP允許在正式日期之前提前采用修訂標(biāo)準(zhǔn)，除非在出版時(shí)另有規(guī)定。如果現(xiàn)有產(chǎn)品的修訂標(biāo)準(zhǔn)已作為最"正式文本"（2.10""中批準(zhǔn)）出版，但尚未達(dá)到正式日期（6個(gè)月，除2.20"""法定產(chǎn)品"），USP另有規(guī)定，禁止在特定標(biāo)準(zhǔn)中提前采用，否則遵守修訂標(biāo)準(zhǔn)并不妨礙發(fā)現(xiàn)或表明符合藥典標(biāo)準(zhǔn)。Thestandardsintherelevantmonograph,generalchapter(s),andGeneralNoticesapplyatalltimesinthelifeofthearticlefromproductiontoexpiration.Itisalsonotedthatthemanufacturer’sspecifications,andmanufacturingpractices(e.g.,QualitybyDesign,ProcessAnalyticalTechnology,andRealTimeReleaseTestinginitiatives),generallyarefollowedtoensurethatthearticlewillcomplywithcompendialstandardsuntilitsexpirationdate,whenstoredasdirected.Everycompendialarticleincommerceshallbesoconstitutedthatwhenexaminedinaccordancewiththeseassaysandtestprocedures,itmeetsallapplicablepharmacopeialrequirements(GeneralNotices,monographs,andgeneralchapters).Thus,anyofficialarticleisexpectedtomeetthecompendialstandardsiftested,andanyofficialarticleactuallytestedasdirectedintherelevantmonographmustmeetsuchstandardstodemonstratecompliance.相關(guān)專論、通則和凡例中的標(biāo)準(zhǔn)適用于產(chǎn)品從生產(chǎn)到失效的整個(gè)生命周期。還應(yīng)注意的是，制造商的規(guī)范和生產(chǎn)實(shí)踐（如設(shè)計(jì)質(zhì)量、工藝分析技術(shù)和實(shí)時(shí)釋放測試計(jì)劃）一般都會得到遵守，以確保產(chǎn)品在按規(guī)定儲存時(shí)，在有效期前都符合藥典標(biāo)準(zhǔn)。商業(yè)中的每種藥典產(chǎn)品在按照這些檢測方法和測試程序進(jìn)行檢查時(shí)，都應(yīng)符合所有適用的藥典要求（總則、專論和通則）。因此，任何法定產(chǎn)品經(jīng)檢測后都應(yīng)符合藥典標(biāo)準(zhǔn)，而任何法定產(chǎn)品按相關(guān)專論的指示進(jìn)行實(shí)際檢測后都必須符合這些標(biāo)準(zhǔn)，以證明其符合要求。Sometests,suchasthoseforDissolutionandUniformityofDosageUnits,requiremultipledosageunitsinconjunctionwithadecisionscheme.Thesetests,albeitusinganumberofdosageunits,areinfactonedetermination.Theseproceduresshouldnotbeconfusedwithstatisticalsamplingplans.Thesimilaritytostatisticalproceduresmayseemtosuggestanintenttomakeinferencetosomelargergroupofunits,butinallcases,statementsaboutwhetherthecompendialstandardismetapplyonlytotheunitstested.Repeats,replicates,statisticalrejectionofoutliers,orextrapolationsofresultstolargerpopulations,aswellasthenecessityandappropriatefrequencyofbatchtesting,areneitherspecifiednorproscribedbythecompendia;suchdecisionsarebasedontheobjectivesofthetesting.Frequencyoftestingandsamplingarelefttothepreferencesordirectionofthoseperformingcompliancetesting,andotherusersofUSP–NF,includingmanufacturers,buyers,orregulatoryauthorities.有些檢驗(yàn)，如溶解度檢驗(yàn)和劑量單位均勻性檢驗(yàn)，需要多個(gè)劑量單位和一個(gè)判定方案。這些檢驗(yàn)雖然使用了多個(gè)劑量單位，但實(shí)際上是一種測定方法。這些程序不應(yīng)與統(tǒng)計(jì)抽樣計(jì)劃相混淆。與統(tǒng)計(jì)程序的相似性似乎暗示著要對更大的一組單位進(jìn)行推斷，但在任何情況下，關(guān)于是否符合藥典標(biāo)準(zhǔn)的聲明都只適用于所測試的單位。重復(fù)、再現(xiàn)、對異常值的統(tǒng)計(jì)剔除、或?qū)⒔Y(jié)果推斷到更大的群體，以及批量測試的必要性和適當(dāng)頻率，既沒有在藥典中明確規(guī)定，也沒有在藥典中加以禁止；這些決定都是根據(jù)測試的目標(biāo)作出的。USP-NF的其他用戶（包括制造商、買家或監(jiān)管機(jī)構(gòu)）自行決定。OfficialproductsarepreparedaccordingtorecognizedprinciplesofgoodmanufacturingpracticeandfromingredientsthatmeetUSPorNFstandards,wherestandardsforsuchingredientsexist(fordietarysupplements,seesection3.10.20ApplicabilityofStandardstoMedicalDevices,DietarySupplements,andTheirComponentsandIngredients).法定產(chǎn)品是根據(jù)公認(rèn)的良好生產(chǎn)規(guī)范原則制備的，其成分符合USP或NF標(biāo)準(zhǔn)（如果有此類成分的標(biāo)準(zhǔn)）（3.10.20"標(biāo)準(zhǔn)對醫(yī)療器械、膳食補(bǔ)充劑及其成分和配料的適用性"）。Officialsubstancesarepreparedaccordingtorecognizedprinciplesofgoodmanufacturingpracticeandfromingredientscomplyingwithspecificationsdesignedtoensurethattheresultantsubstancesmeettherequirementsofthecompendialmonographs.法定產(chǎn)品是根據(jù)公認(rèn)的良好生產(chǎn)規(guī)范原則，用符合規(guī)范的成分制備的，目的是確保制得的物質(zhì)符合藥典專論的要求。3.10.10.ApplicabilityofStandardstoDrugProducts,DrugSubstances,and3.10.10.ApplicabilityofStandardstoDrugProducts,DrugSubstances,andExcipients標(biāo)準(zhǔn)對藥品、原料藥和輔料的適用性TheapplicableUSPorNFstandardappliestoanyarticlemarketedintheUnitedStatesthat(1)isrecognizedinthecompendiumand(2)isintendedorlabeledforuseasadrugorasaningredientinadrug.Sucharticles(drugproducts,drugsubstances,andexcipients)includebothhumandrugs(whetherdispensedbyprescription,“overthecounter”,orotherwise),aswellasanimaldrugs.Theapplicablestandardappliestosucharticleswhetherornottheaddeddesignation“USP”or“NF”isused.Thestandardsapplyequallytoarticlesbearingtheofficialtitlesornamesderivedbytranspositionofthedefinitivewordsofofficialtitlesortranspositionintheorderofthenamesoftwoormoredrugsubstancesinofficialtitles,orwherethereisuseofsynonymswiththeintentoreffectofsuggestingasignificantdegreeofidentitywiththeofficialtitleorname.適用的USP或NF標(biāo)準(zhǔn)適用于在美國市場上銷售的任何產(chǎn)品，這些產(chǎn)品(1)得到藥典認(rèn)可，(2)打算或標(biāo)明用作藥物或藥物成分。此類產(chǎn)品（藥品、原料藥和輔料）既包括人類藥物（無論是處方藥、"非處方藥"還是其他藥物），也包括動物藥物。無論是否添加了"USP"或"NF"名稱，適用標(biāo)準(zhǔn)都適用于此類產(chǎn)品。這些標(biāo)準(zhǔn)同樣適用于帶有正式名稱或通過調(diào)換正式名稱中的定語或調(diào)換正式名稱中兩種或兩種以上原料藥名稱的順序而產(chǎn)生的名稱的產(chǎn)品，或使用同義詞的意圖或效果是暗示與正式名稱或名稱有很大程度的相同之處的產(chǎn)品。3.10.20.ApplicabilityofStandardstoMedicalDevices,DietarySupplements,and3.10.20.ApplicabilityofStandardstoMedicalDevices,DietarySupplements,andTheirComponentsandIngredients.標(biāo)準(zhǔn)對醫(yī)療器械、膳食補(bǔ)充劑及其成分和配料的適用性AnarticlerecognizedinUSPorNFshallcomplywiththecompendialstandardsifthearticleisamedicaldevice,componentintendedforamedicaldevice,dietarysupplement,dietaryingredient,orotheringredientthatisintendedforincorporationintoadietarysupplement,andislabeledasconformingtotheUSPorNF.USPNF認(rèn)可的產(chǎn)品應(yīng)符合藥典標(biāo)準(zhǔn)，前提是該產(chǎn)品是醫(yī)療器械、醫(yī)療器械部件、膳食補(bǔ)充劑、膳食成分或其他旨在加入膳食補(bǔ)充劑的成分，并標(biāo)明符合USPNF標(biāo)準(zhǔn)。Generally,dietarysupplementsarepreparedfromingredientsthatmeetUSP,NF,orFoodChemicalsCodexstandards.Wheresuchstandardsdonotexist,substancesmaybeusedindietarysupplementsiftheyhavebeenshowntobeofacceptablefoodgradequalityusingothersuitableprocedures.一般來說，膳食補(bǔ)充劑是用符合USP、NF或食品化學(xué)法典標(biāo)準(zhǔn)的成分制成的。在沒有此類標(biāo)準(zhǔn)的情況下，如果使用其他合適的程序證明這些物質(zhì)具有可接受的食品級質(zhì)量，則可將其用于膳食補(bǔ)充劑。本文件由AI本文件由AI進(jìn)行翻譯，僅供行業(yè)交流使用，譯文準(zhǔn)確性不做最終負(fù)責(zé)，僅供參考3.10.303.10.30ApplicabilityofStandardstothePracticeofCompounding標(biāo)準(zhǔn)對復(fù)方制劑生產(chǎn)的適用性USPcompoundingpracticestandards,PharmaceuticalCompounding—NonsterilePreparations795andPharmaceuticalCompounding—SterilePreparations〈797,asappropriate,applytocompoundingpracticeoractivityregardlessofwhetheramonographexistsforthecompoundedpreparationorthesechaptersarereferencedinsuchamonographIntheUnitedStates,〈795〉and〈797〉arenotapplicabletodrugscompoundedbyentitiesregisteredwithFDAasoutsourcingfacilitiesasdefinedbyFDCA§503B,becausesuchfacilitiesarerequiredtocomplywithFDA’scurrentgoodmanufacturingpracticerequirements.美國藥典復(fù)方制劑實(shí)踐標(biāo)準(zhǔn)藥物復(fù)方制劑-非無菌制劑〈795〉和藥物復(fù)方制劑-無菌制劑〈797〉酌情適用于復(fù)方制劑實(shí)踐或活動，而不論復(fù)方制劑是否存在專論，也不論此類專論是否引用了這些章節(jié)。在美國，〈795〉和〈797〉不適用于在FDA注冊為FDCA第503B節(jié)定義的外包設(shè)施的實(shí)體所配制的藥物，因?yàn)檫@類設(shè)施必須遵守FDA現(xiàn)行的良好生產(chǎn)規(guī)范要求。Compoundedpreparations,includingdrugproductscompoundedbyoutsourcingfacilities,mayalsobesubjecttoapplicablemonographs;seesection2.20OfficialArticlesandsection4.10Monographs.2.20""4.10"專論"。3.10.403.10.40ApplicabilityofGlobalHealthMonographs全球衛(wèi)生專論的適用性GlobalHealthMonographs(GHM)donotapplytoproductsmarketedintheUnitedStates.MonographsinthissectionoftheUSP–NFarenotconsidered“applicable”USP–NFmonographsforuseinpharmacycompoundingintheUnitedStatesundertheFederalFood,Drug,andCosmeticAct.GHMsareprovidedforpossibleuseoutsideoftheUnitedStates,atthediscretionofindividualgovernmentauthorities.全球保健專論(GHM)不適用于在美國銷售的產(chǎn)品。根據(jù)《聯(lián)邦食品、藥品和化妝品法》，USP-NF本節(jié)""USP-NF專論。GHM供美國境外使用，由各政府部門自行決定。ApplicabilityofaGHM,inwholeorinpart,alongwiththeapplicabilityofassociatedGeneralNoticesandgeneralchapterrequirements,inwholeorinpart,isatthediscretionofindividualgovernmentauthorities.全球健康手冊的全部或部分適用性，以及相關(guān)的凡例和通則要求的全部或部分適用性，由各政府當(dāng)局自行決定。WhereaproductpurportstocomplywiththerequirementsofanofficialGHM,itisrecommendedthattheproductlabelorlabelingclearlyspecifyconformancetoaGHM,e.g.,“USP-GHM”or“USP–GH”.Thedesignations,“USP–NF”,“USP”,and“NF”shouldbeusedonlytoindicateconformancetoUSPorNFmonographsoutsideofGHMs(seesection3.20IndicatingConformance).如果產(chǎn)品聲稱符合官方GHM的要求，建議在產(chǎn)品標(biāo)簽上明確注明符合GHM"USP-GHM"或"USP-GH"USP-NF""USP"NFGHMUSPNF（見第3.20"表示符合性"）。Thedesignation“USP–GHM”or“USP–GH”onthelabel"USP-GHM"USP-GHmaynotanddoesnotconstituteanendorsementbyUSPanddoesnotrepresentassurancebyUSPthatthearticleisknowntocomplywiththerelevantstandards.USPmayseeklegalredressifanarticlepurportstobeorisrepresentedasanofficialGHMarticleandsuchclaimisdeterminedbyUSPnottobemadeingoodfaith.USP可能也不會認(rèn)可該產(chǎn)品，也不代表USP保證該產(chǎn)品符合相關(guān)標(biāo)準(zhǔn)。如果某產(chǎn)品聲稱是或被表示為官方GHM產(chǎn)品，而USP認(rèn)定該聲稱并非出于善意，USP可能會尋求法律補(bǔ)救。EnforcementofGHMrequirementsistheresponsibilityofgovernmentauthoritiesoutsideoftheU.S.USPhasnoroleinenforcement.GHM要求的執(zhí)行由美國以外的政府部門負(fù)責(zé)，USP不參與執(zhí)行。3.20IndicatingConformance顯示一致性Adrugproduct,drugsubstance,orexcipientmayusethedesignation“USP”or“NF”inconjunctionwithitsofficialtitleorelsewhereonthelabelonlywhen(1)amonographisprovidedinthespecifiedcompendiumand(2)thearticlecomplieswiththeidentityprescribedinthespecifiedcompendium.(1)特定藥典提供了專論，且(2)產(chǎn)品符合特定藥典規(guī)定的特征時(shí)，才可在其正式名稱或標(biāo)簽的其他地方使用"USP"或"NF"名稱。Whenadrugproduct,drugsubstance,compoundedpreparation,orexcipientdiffersfromtherelevantUSPorNFstandardofstrength,quality,orpurity,asdeterminedbytheapplicationofthetests,procedures,andacceptancecriteriasetforthintherelevantcompendium,itsdifferenceshallbeplainlystatedonitslabel.當(dāng)藥品、原料藥、復(fù)方制劑或輔料在強(qiáng)度、質(zhì)量或純度方面不同于相關(guān)USP或NF標(biāo)準(zhǔn)（根據(jù)相關(guān)藥典規(guī)定的測試、程序和可接受標(biāo)準(zhǔn)確定）時(shí)，應(yīng)在其標(biāo)簽上明確說明其差異。Whenadrugproduct,drugsubstance,compoundedpreparation,orexcipientfailstocomplywiththeidentityprescribedinUSPorNForcontainsanaddedsubstancethatinterfereswiththeprescribedtestsandprocedures,thearticleshallbedesignatedbyanamethatisclearlydistinguishinganddifferentiatingfromanynamerecognizedinUSPorNF.當(dāng)藥品、原料藥、復(fù)方制劑或賦形劑不符合USP或NF規(guī)定的特性，或含有干擾規(guī)定的測試和程序的添加物質(zhì)時(shí)，產(chǎn)品的名稱應(yīng)明顯區(qū)別于USPNF中認(rèn)可的任何名稱。Amedicaldevice,dietarysupplement,oringredientorcomponentofamedicaldeviceordietarysupplementmayusethedesignation“USP”or“NF”inconjunctionwithitsofficialtitleorelsewhereonthelabelonlywhen(1)amonographisprovidedinthespecifiedcompendiumand(2)thearticlecomplieswiththemonographstandardsandotherapplicablestandardsinthatcompendium.醫(yī)療器械、膳食補(bǔ)充劑或醫(yī)療器械或膳食補(bǔ)充劑的成分或組分只有在以下情況下才可在其正式名稱或標(biāo)簽"USP"NF名稱：(1)特定藥典中提供了專論；(2)產(chǎn)品符合該藥典中的專論標(biāo)準(zhǔn)和其他適用標(biāo)準(zhǔn)。Thedesignation“USP–NF”maybeusedonthelabelofanarticleprovidedthatthelabelalsobearsastatementsuchas“MeetsNFstandardsaspublishedbyUSP”,indicatingtheparticularcompendiumtowhichthearticlepurportstoapply.USP-NF"名稱可用于產(chǎn)品標(biāo)簽上，條件是標(biāo)簽上還必須注明"符合USP公布的NF標(biāo)準(zhǔn)"等字樣，并注明產(chǎn)品聲稱適用的特定藥典。Whentheletters“USP”,“NF”,or“USP–NF”areusedonthelabelofanarticletoindicatecompliancewithcompendialstandards,thelettersshallappearinconjunctionwiththeofficialtitleofthearticle.Thelettersarenottobeenclosedinanysymbolsuchasacircle,square,etc.,andshallappearincapitalletters."USP"、"NF"USP-NF表示符合藥典標(biāo)準(zhǔn)時(shí)，字母應(yīng)與產(chǎn)品的正式名稱一起出現(xiàn)。字母不得與任何符號（如圓形、方形等）結(jié)合，并應(yīng)以大寫字母顯示。IfadietarysupplementdoesnotcomplywithallapplicablecompendialrequirementsbutcontainsoneormoredietaryingredientsorotheringredientsthatarerecognizedinUSPorNF,theindividualingredient(s)maybedesignatedascomplyingwithUSPorNFstandardsorbeingofUSPorNFqualityprovidedthatthedesignationislimitedtotheindividualingredient(s)anddoesnotsuggestthatthedietarysupplementcomplieswithUSPstandards.如果膳食補(bǔ)充劑不符合所有適用的藥典要求，但含有一種或多種膳食成分或USP或NF認(rèn)可的其他成分，則可將個(gè)別成分指定為符合USP或NF標(biāo)準(zhǔn)或具有USP或NF質(zhì)量，但指定僅限于個(gè)別成分，并不USP標(biāo)準(zhǔn)。MONOGRAPHSANDGENERALCHAPTERS專論和通則4.10Monographs專論Monographssetforththearticle’sname,definition,specification,andotherrequirementsrelatedtopackaging,storage,andlabeling.Thespecificationconsistsoftests,procedures,andacceptancecriteriathathelpensuretheidentity,strength,quality,andpurityofthearticle.Forgeneralrequirementsrelatingtospecificmonographsections,seesection5.MonographComponents.Becausemonographsmaynotprovidestandardsforallrelevantcharacteristics,someofficialsubstancesmayconformtotheUSPorNFstandardbutdifferwithregardtononstandardizedpropertiesthatarerelevanttotheiruseinspecificpreparations.Toassuresubstitutabilityinsuchinstances,usersmaywishtoascertainfunctionalequivalenceordeterminesuchcharacteristicsbeforeuse.專論規(guī)定了產(chǎn)品的名稱、定義、規(guī)格以及與包裝、儲存和標(biāo)簽有關(guān)的其他要求。規(guī)范包括有助于確保產(chǎn)品5節(jié)。專論組成部分。由于專論可能無法提供所有相關(guān)特性的標(biāo)準(zhǔn)，因此某些法定產(chǎn)品可能符合USP或NF標(biāo)準(zhǔn)，但在與特定制劑用途相關(guān)的非標(biāo)準(zhǔn)化特性方面存在差異。在這種情況下，為確?？商娲?，用戶可能希望在使用前確定功能等同性或確定此類特性。0.10ApplicabilityofTestProcedures分析過程的適用性Asinglemonographmayincludemorethanonetest,procedure,and/oracceptancecriterionforthesameattribute.Unlessotherwisespecifiedinthemonograph,alltestsarerequirements.Insomecases,monographinstructionsallowtheselectionofteststhatreflectattributesofdifferentmanufacturers’articles,suchasdifferentpolymorphicforms,impurities,hydrates,anddissolution.Monographinstructionsindicatethetests,procedures,and/oracceptancecriteriatobeusedandtherequiredlabeling.一個(gè)專論可能包含多個(gè)針對同一屬性的檢驗(yàn)、程序和/或可接受標(biāo)準(zhǔn)。除非專論中另有規(guī)定，否則所有檢驗(yàn)都是要求。在某些情況下，專論說明書允許選擇反映不同制造商產(chǎn)品屬性的試驗(yàn)，如不同的多晶型、雜質(zhì)、水合物和溶解度。專論說明書說明所用的試驗(yàn)、程序和/或可接受標(biāo)準(zhǔn)以及所要求的標(biāo)簽。TheorderinwhichthetestsarelistedinthemonographisbasedontheorderinwhichtheyareapprovedbytherelevantExpertCommitteeforinclusioninthemonograph.Test1isnotnecessarilythetestfortheinnovatororforthereferenceproduct.Dependingonmonographinstructions,alabelingstatementisnottypicallyrequiredifTest1isused.1不一定是創(chuàng)新產(chǎn)品或參比產(chǎn)品的試驗(yàn)。根據(jù)專論的說明，如果使用試驗(yàn)1，一般不需要標(biāo)簽說明。0.20AcceptanceCriteria可接受標(biāo)準(zhǔn)Theacceptancecriteriaallowforanalyticalerror,forunavoidablevariationsinmanufacturingandcompounding,andfordeteriorationtoanextentconsideredacceptableunderpracticalconditions.Theexistenceofcompendialacceptancecriteriadoesnotconstituteabasisforaclaimthatanofficialsubstancethatmorenearlyapproaches100%purity“exceeds”compendialquality.Similarly,thefactthatanarticlehasbeenpreparedtotightercriteriathanthosespecifiedinthemonographdoesnotconstituteabasisforaclaimthatthearticle“exceeds”thecompendialrequirements.可接受標(biāo)準(zhǔn)允許存在分析誤差、制造和配制過程中不可避免的差異，以及在實(shí)際條件下可接受的變質(zhì)程度100%""藥典質(zhì)量的依據(jù)。同樣，按照比專論規(guī)定更嚴(yán)格的標(biāo)準(zhǔn)制備產(chǎn)品的事實(shí)，也不構(gòu)成聲稱該產(chǎn)品"超過"藥典要求的依據(jù)。Anofficialproductshallbeformulatedwiththeintenttoprovide100%ofthequantityofeachingredientdeclaredonthelabel.Wheretheminimumamountofasubstancepresentinadietarysupplementisrequiredbylawtobehigherthantheloweracceptancecriterionallowedforinthemonograph,theupperacceptancecriterioncontainedinthemonographmaybeincreasedbyacorrespondingamount.法定產(chǎn)品必須100%提供標(biāo)簽上標(biāo)明的每種成分的含量。如果法律要求膳食補(bǔ)充劑中某種物質(zhì)的最低含量高于專論中允許的較低接受標(biāo)準(zhǔn)，則專論中的較高接受標(biāo)準(zhǔn)可相應(yīng)增加。Theacceptancecriteriaspecifiedinindividualmonographsandinthegeneralchaptersforcompoundedpreparationsarebasedonsuchattributesofqualityasmightbeexpectedtocharacterizeanarticlecompoundedfromsuitablebulkdrugsubstancesandingredients,usingtheproceduresprovidedorrecognizedprinciplesofgoodcompoundingpractice,asdescribedinthesecompendia.專論和總論中規(guī)定的復(fù)方制劑可接受標(biāo)準(zhǔn)，是根據(jù)這些藥典中規(guī)定的程序或公認(rèn)的良好復(fù)方制劑操作原則，從合適的原藥和配料中復(fù)方制得的產(chǎn)品的預(yù)期質(zhì)量特性制定的。4.20GeneralChapters通則Eachgeneralchapterisassignedanumberthatappearsinanglebracketsadjacenttothechaptername(e.g.,Chromatography〈621〉Generalchaptersmaycontainthefollowing:每個(gè)通則都有一個(gè)編號，編號出現(xiàn)在章節(jié)名稱旁邊的角括號中（例如，《色譜法〈621〉》）。通則可包含以下內(nèi)容：Descriptionsoftestsandproceduresforapplicationthroughindividualmonographs,通過專論對應(yīng)用的測試和程序進(jìn)行說明、Descriptionsandspecificationsofconditionsandpracticesforpharmaceuticalcompounding,藥品配制條件和規(guī)范的說明和規(guī)格、Generalinformationfortheinterpretationofthecompendialrequirements,解釋藥典要求的一般信息，Descriptionsofgeneralpharmaceuticalstorage,dispensing,andpackagingpractices,or一般藥品儲存、配發(fā)和包裝規(guī)范的說明，或Generalguidancetomanufacturersofofficialsubstancesorofficialproducts.對官方物質(zhì)或官方產(chǎn)品制造商的一般指導(dǎo)。Whenageneralchapterisreferencedinamonograph,acceptancecriteriamaybepresentedafteracolon.在專論中引用通則時(shí)，可在冒號后列出可接受標(biāo)準(zhǔn)。Somechaptersmayserveasintroductoryoverviewsofatestorofanalyticaltechniques.Theymayreferenceothergeneralchaptersthatcontaintechniques,detailsoftheprocedures,and,attimes,acceptancecriteria.有些章節(jié)可作為測試或分析技術(shù)的介紹性概述。這些章節(jié)可能會參考其他包含技術(shù)、程序細(xì)節(jié)以及可接受標(biāo)準(zhǔn)的通則。MONOGRAPHCOMPONENTS專論的組成部分5.10MolecularFormula分子式Theuseofthemolecularformulafortheofficialsubstance(s)namedindefiningtherequiredstrengthofacompendialarticleisintendedto