FDC Act Chapter III Prohibited Acts and Penalties 禁止行为及罚则.docx

FDC Act Chapter III Prohibited Acts and Penalties 禁止行为及罚则.docx

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FDCActChapterIIIProhibitedActsandPenalties禁止行为及罚则

FD&CActChapterIII:

ProhibitedActsandPenalties

SEC.301.[21USC§331]Prohibitedacts

Note:

revisionswerepostedtothissectioninFebruary2008.

Thefollowingactsandthecausingthereofareherebyprohibited:

1

（a）Theintroductionordeliveryforintroductionintointerstatecommerceofanyfood,drug,device,orcosmeticthatisadulteratedormisbranded.

（b）Theadulterationormisbrandingofanyfood,drug,device,orcosmeticininterstatecommerce.

（c）Thereceiptininterstatecommerceofanyfood,drug,device,orcosmeticthatisadulteratedormisbranded,andthedeliveryorproffereddeliverythereofforpayorotherwise.

（d）Theintroductionordeliveryforintroductionintointerstatecommerceofanyarticleinviolationofsection404,505or564.

（e）Therefusaltopermitaccesstoorcopyingofanyrecordasrequiredbysection412,414,416,417（g）,504,564,703,704（a）,760,or761;orthefailuretoestablishormaintainanyrecord,ormakeanyreport,requiredundersection412,414（b）,416,417,504,505（i）or（k）,512（a）（4）（C）,512（j）,（l）or（m）,572（i）,

2515（f）,519,564,760,or761ortherefusaltopermitaccesstoorverificationorcopyingofanysuchrequiredrecord.

（f）Therefusaltopermitentryorinspectionasauthorizedbysection704.

（g）Themanufacture,withinanyTerritoryofanyfood,drug,device,orcosmeticthatisadulteratedormisbranded.

（h）Thegivingofaguarantyorundertakingreferredtoinsection303（c）

（2）,whichguarantyorundertakingisfalse,exceptbyapersonwhorelieduponaguarantyorundertakingtothesameeffectsignedby,containingthenameandaddressof,thepersonresidingintheUnitedStatesfromwhomhereceivedingoodfaiththefood,drug,device,orcosmetic;orthegivingofaguarantyorundertakingreferredtoinsection303（c）（3）,whichguarantyorundertakingisfalse.

（i）

（1）Forging,counterfeiting,simulating,orfalselyrepresenting,orwithoutproperauthorityusinganymark,stamp,tag,label,orotheridentificationdeviceauthorizedorrequiredbyregulationspromulgatedundertheprovisionsofsection404or721.

（2）Making,selling,disposingof,orkeepinginpossession,control,orcustody,orconcealinganypunch,die,plate,stone,orotherthingdesignedtoprint,imprint,orreproducethetrademark,tradename,orotheridentifyingmark,imprint,ordeviceofanotheroranylikenessofanyoftheforegoinguponanydrugorcontainerorlabelingthereofsoastorendersuchdrugacounterfeitdrug.

（3）Thedoingofanyactwhichcausesadrugtobeacounterfeitdrug,orthesaleordispensing,ortheholdingforsaleordispensing,ofacounterfeitdrug.

（j）Theusingbyanypersontohisownadvantageorrevealing,otherthantotheSecretaryorofficersoremployeesoftheDepartment,ortothecourtswhenrelevantinanyjudicialproceedingunderthisAct,anyinformationacquiredunderauthorityofsection404,409,412,414,505,510,512,513,514,515,516,518,519,520,571,572,573, 3704,708,or721concerninganymethodorprocesswhichasatradesecretisentitledtoprotection;ortheviolatingofsection408（i）

（2）oranyregulationissuedunderthatsection. 4ThisparagraphdoesnotauthorizethewithholdingofinformationfromeitherHouseofCongressorfrom,totheextentofmatterwithinitsjurisdiction,anycommitteeorsubcommitteeofsuchcommitteeoranyjointcommitteeofCongressoranysubcommitteeofsuchjointcommittee.

（k）Thealteration,mutilation,destruction,obliteration,orremovalofthewholeoranypartofthelabelingof,orthedoingofanyotheractwithrespectto,afood,drug,device,orcosmetic,ifsuchactisdonewhilesucharticleisheldforsale（whetherornotthefirstsale）aftershipmentininterstatecommerceandresultsinsucharticlebeingadulteratedormisbranded.

（l）[Deleted] 5

（m）Thesaleorofferingforsaleofcoloredoleomargarineorcoloredmargarine,orthepossessionorservingofcoloredoleomargarineorcoloredmargarineinviolationofsections407（b）or407（c）.

（n）Theusing,inlabeling,advertisingorothersalespromotionofanyreferencetoanyreportoranalysisfurnishedincompliancewithsection704.

（o）Inthecaseofaprescriptiondrugdistributedorofferedforsaleininterstatecommerce,thefailureofthemanufacturer,packer,ordistributorthereoftomaintainfortransmittal,ortotransmit,toanypractitionerlicensedbyapplicableStatelawtoadministersuchdrugwhomakeswrittenrequestforinformationastosuchdrug,trueandcorrectcopiesofallprintedmatterwhichisrequiredtobeincludedinanypackageinwhichthatdrugisdistributedorsold,orsuchotherprintedmatterasisapprovedbytheSecretary.NothinginthisparagraphshallbeconstruedtoexemptanypersonfromanylabelingrequirementimposedbyorunderotherprovisionsofthisAct.

（p）Thefailuretoregisterinaccordancewithsection510,thefailuretoprovideanyinformationrequiredbysection510（j）or510（k）,21USC§360（j）or（k）]orthefailuretoprovideanoticerequiredbysection510（j）

（2）.

（q）

（1）Thefailureorrefusalto（A）complywithanyrequirementprescribedundersection518or520（g）,（B）furnishanynotificationorothermaterialorinformationrequiredbyorundersection519or520（g）,or（C）complywitharequirementundersection522.

（2）Withrespecttoanydevice,thesubmissionofanyreportthatisrequiredbyorunderthisActthatisfalseormisleadinginanymaterialrespect.

（r）Themovementofadeviceinviolationofanorderundersection304（g）ortheremovaloralterationofanymarkorlabelrequiredbytheordertoidentifythedeviceasdetained.

（s）Thefailuretoprovidethenoticerequiredbysection412（c）or412（e）,thefailuretomakethereportsrequiredbysection412（f）

（1）（B）,thefailuretoretaintherecordsrequiredbysection412（b）（4）,orthefailuretomeettherequirementsprescribedundersection412（f）（3）.

（t）Theimportationofadruginviolationofsection801（d）

（1）,thesale,purchase,ortradeofadrugordrugsampleortheoffertosell,purchase,ortradeadrugordrugsampleinviolationofsection503（c）,thesale,purchase,ortradeofacoupon,theoffertosell,purchase,ortradesuchacoupon,orthecounterfeitingofsuchacouponinviolationofsection503（c）

（2）,thedistributionofadrugsampleinviolationofsection503（d）orthefailuretootherwisecomplywiththerequirementsofsection503（d）,orthedistributionofdrugsinviolationofsection503（e）orthefailuretootherwisecomplywiththerequirementsofsection503（e）.

（u）Thefailuretocomplywithanyrequirementsoftheprovisionsof,oranyregulationsorordersoftheSecretary,undersection512（a）（4）（A）,512（a）（4）（D）,or512（a）（5）.

（v）Theintroductionordeliveryforintroductionintointerstatecommerceofadietarysupplementthatisunsafeundersection413.

（w）Themakingofaknowinglyfalsestatementinanystatement,certificateofanalysis,record,orreportrequiredorrequestedundersection801（d）（3）;thefailuretosubmitacertificateofanalysisasrequiredundersuchsection;thefailuretomaintainrecordsortosubmitrecordsorreportsasrequiredbysuchsection;thereleaseintointerstatecommerceofanyarticleorportionthereofimportedintotheUnitedStatesundersuchsectionoranyfinishedproductmadefromsucharticleorportion,exceptforexportinaccordancewithsection801（e）or802,orwithsection351（h）ofthePublicHealthServiceAct[42USC§262（h）];orthefailuretosoexportortodestroysuchanarticleorportionsthereof,orsuchafinishedproduct.

（x）Thefalsificationofadeclarationofconformitysubmittedundersection514（c）orthefailureorrefusaltoprovidedataorinformationrequestedbytheSecretaryunderparagraph（3）ofsuchsection.

（y）Inthecaseofadrug,device,orfood–

（1）thesubmissionofareportorrecommendationbyapersonaccreditedundersection523thatisfalseormisleadinginanymaterialrespect;

（2）thedisclosurebyapersonaccreditedundersection523ofconfidentialcommercialinformationoranytradesecretwithouttheexpresswrittenconsentofthepersonwhosubmittedsuchinformationorsecrettosuchperson;or

（3）thereceiptbyapersonaccreditedundersection523ofabribeinanyformorthedoingofanycorruptactbysuchpersonassociatedwitharesponsibilitydelegatedtosuchpersonunderthisAct.

（z）[Terminated]6

（aa）Theimportationofaprescriptiondruginviolationofsection804,thefalsificationofanyrecordrequiredtobemaintainedorprovidedtotheSecretaryundersection,oranyotherviolationofregulationsundersuchsection.

（bb）Thetransferofanarticleoffoodinviolationofanorderundersection304（h）,ortheremovaloralterationofanymarkorlabelrequiredbytheordertoidentifythearticleasdetained.

（cc）TheimportingorofferingforimportintotheUnitedStatesofanarticleoffoodby,withtheassistanceof,oratthedirectionof,apersondebarredundersection306（b）（3）.

（dd）Thefailuretoregisterinaccordancewithsection415.

（ee）TheimportingorofferingforimportintotheUnitedStatesofanarticleoffoodinviolationoftherequirementsundersection801（m）.

（ff）TheimportingorofferingforimportintotheUnitedStatesofadrugordevicewithrespecttowhichthereisafailuretocomplywitharequestoftheSecretarytosubmittotheSecretaryastatementundersection801（o）.

（gg）Theknowingfailuretocomplywithparagraph（7）（E）ofsection704（g）;theknowinginclusionbyapersonaccreditedunderparagraph

（2）ofsuchsectionoffalseinformationinaninspectionreportunderparagr