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