美国FDA《联邦规章典集》(CFR)第21篇目录(中英文)

美国FDA《联邦规章典集》（CFR）第21篇目录中文版概述：美国《联邦规章典集》（CodeofFederalRegulations，CFR）第21篇“食品与药品”（Title21―FoodandDrugs）共有9卷（Volume）、3章（Chapter）、1499部（Parts）。其中：第1―8卷第1章第1―1299部，为健康与人类服务部食品与药品管理局（FoodandDrugAdministration，DepartmentofHealthandHumanServices）的规章；第9卷第2章第1300―1399部，为司法部毒品强制执行局（DrugEnforcementAdministration，DepartmentofJustice）的规章；第9卷第3章第1400―1499部，为毒品控制政策办公室（OfficeofNationalDrugControlPolicy）的规章。第21篇“食品与药品”（Title21―FoodandDrugs）的概况卷（Volume）章（Chapter）部（Parts）规制机关（RegulatoryEntity）1Ⅰ1-99健康与人类服务部食品与药品管理局（FOODANDDRUGADMINISTRATION,DEPARTMENTOFHEALTHANDHUMANSERVICES）2100-1693170-1994200-2995300-4996500-5997600-7998800-12999Ⅱ1300-1399司法部毒品强制执行局（DrugEnforcementAdministration，DepartmentofJustice）Ⅲ1400-1499毒品控制政策办公室（OfficeofNationalDrugControlPolicy）第21篇“食品与药品”（Title21―FoodandDrugs）的章、部目录部(Part)中译文原英文第Ⅰ章―健康与人类服务部食品与药品管理局（CHAPTERⅠ―FOODANDDRUGADMINISTRATION,DEPARTMENTOFHEALTHANDHUMANSERVICES）第A分章―总则（SUBCHAPTERA―GENERAL）1一般强制执行规章GENERALENFORCEMENTREGULATIONS2一般行政规则与决定GENERALADMINISTRATIVERULINGSANDDECISIONS3产品管辖权PRODUCTJURISDICTION5组织ORGANIZATION7强制执行政策ENFORCEMENTPOLICY10行政规范与程序ADMINISTRATIVEPRACTICESANDPROCEDURES11电子化记录；电子化签名ELECTRONICRECORDS;ELECTRONICSIGNATURES12正式证据的公众听证FORMALEVIDENTIARYPUBLICHEARING13在公众质询委员会前的公众听证PUBLICHEARINGBEFOREAPUBLICBOARDOFINQUIRY14在公众咨询委员会前的公众听证PUBLICHEARINGBEFOREAPUBLICADVISORYCOMMITTEE15在FDA局长前的公众听证PUBLICHEARINGBEFORETHECOMMISSIONER16在FDA前的规制性听证REGULATORYHEARINGBEFORETHEFOODANDDRUGADMINISTRATION17行政罚款听证CIVILMONEYPENALTIESHEARINGS19行为标准与利益冲突STANDARDSOFCONDUCTANDCONFLICTSOFINTEREST20公共信息PUBLICINFORMATION21隐私保护PROTECTIONOFPRIVACY25环境影响考虑ENVIRONMENTALIMPACTCONSIDERATIONS26药品良好制造规范报告、医疗器械质量体系核查报告以及某些医疗器械产品评价报告的互认：美国与欧共体MUTUALRECOGNITIONOFPHARMACEUTICALGOODMANUFACTURINGPRACTICEREPORTS,MEDICALDEVICEQUALITYSYSTEMAUDITREPORTS,ANDCERTAINMEDICALDEVICEPRODUCTEVALUATIONREPORTS:UNITEDSTATESANDTHEEUROPEANCOMMUNITY50人类受试者的保护PROTECTIONOFHUMANSUBJECTS54临床试验者的财务公开FINANCIALDISCLOSUREBYCLINICALINVESTIGATORS56机构审查委员会INSTITUTIONALREVIEWBOARDS58对非临床实验室研究的良好实验室规范GOODLABORATORYPRACTICEFORNONCLINICALLABORATORYSTUDIES60专利期恢复PATENTTERMRESTORATION70色素添加剂COLORADDITIVES71色素添加剂申请COLORADDITIVEPETITIONS73免除认证的色素添加剂的列表LISTINGOFCOLORADDITIVESEXEMPTFROMCERTIFICATION74适用认证的色素添加剂的列表LISTINGOFCOLORADDITIVESSUBJECTTOCERTIFICATION80色素添加剂认证COLORADDITIVECERTIFICATION81用于食品、药品和化妆品的临时性色素添加剂的一般规范和一般限制GENERALSPECIFICATIONSANDGENERALRESTRICTIONSFORPROVISIONALCOLORADDITIVESFORUSEINFOODS,DRUGS,ANDCOSMETICS82经认证的临时性列表的色素和规范的列表LISTINGOFCERTIFIEDPROVISIONALLYLISTEDCOLORSANDSPECIFICATIONS83-98[预留的][Reserved]99已上市的药品、生物制品和器械的未经批准的/新的用途的信息的发布DISSEMINATIONOFINFORMATIONONUNAPPROVED/NEWUSESFORMARKETEDDRUGS,BIOLOGICS,ANDDEVICES第B分章―用于人类消费的食品（SUBCHAPTERB―FOODFORHUMANCONSUMPTION）100总则GENERAL101食品标识FOODLABELING102非标准化食品的普通的或者通常的名称COMMONORUSUALNAMEFORNONSTANDARDIZEDFOODS104食品的营养质量指南NUTRITIONALQUALITYGUIDELINESFORFOODS105特殊膳食用途的食品FOODSFORSPECIALDIETARYUSE106婴儿配方母乳替代食品质量控制程序INFANTFORMULAQUALITYCONTROLPROCEDURES107婴儿配方母乳替代食品INFANTFORMULA108紧急许可控制EMERGENCYPERMITCONTROL109在人类食品与食品-包装材料中的不可避免的污染物UNAVOIDABLECONTAMINANTSINFOODFORHUMANCONSUMPTIONANDFOOD-PACKAGINGMATERIAL110在制造、包装或者保存人类食品中的现行良好制造规范CURRENTGOODMANUFACTURINGPRACTICEINMANUFACTURING,PACKING,ORHOLDINGHUMANFOOD113装在密封容器中的热加工低酸食品THERMALLYPROCESSEDLOW-ACIDFOODSPACKAGEDINHERMETICALLYSEALEDCONTAINERS114酸化食品ACIDIFIEDFOODS115带壳蛋SHELLEGGS119存在显著或者不合理风险的膳食补充剂DIETARYSUPPLEMENTSTHATPRESENTASIGNIFICANTORUNREASONABLERISK120危害分析与关键控制点（HACCP）体系HAZARDANALYSISANDCRITICALCONTROLPOINT(HACCP)SYSTEMS123鱼与渔业产品FISHANDFISHERYPRODUCTS129饮用水加工与装瓶PROCESSINGANDBOTTLINGOFBOTTLEDDRINKINGWATER130食品标准：总则FOODSTANDARDS:GENERAL131乳与奶油MILKANDCREAM133乳酪与相关乳酪产品CHEESESANDRELATEDCHEESEPRODUCTS135冷冻点心FROZENDESSERTS136烘焙产品BAKERYPRODUCTS137谷物粉与相关产品CEREALFLOURSANDRELATEDPRODUCTS139通心粉与面条产品MACARONIANDNOODLEPRODUCTS145罐装水果CANNEDFRUITS146罐装水果汁CANNEDFRUITJUICES150水果黄油、果冻、防腐剂以及相关产品FRUITBUTTERS,JELLIES,PRESERVES,ANDRELATEDPRODUCTS152水果馅饼FRUITPIES155罐装蔬菜CANNEDVEGETABLES156蔬菜汁VEGETABLEJUICES158冷冻蔬菜FROZENVEGETABLES160蛋与蛋制品EGGSANDEGGPRODUCTS161鱼与有壳的水生动物FISHANDSHELLFISH163可可制品CACAOPRODUCTS164树坚果与花生制品TREENUTANDPEANUTPRODUCTS165饮料BEVERAGES166人造黄油MARGARINE168增甜剂与餐桌糖浆SWEETENERSANDTABLESIRUPS169食品敷料与调味料FOODDRESSINGSANDFLAVORINGS170食品添加剂FOODADDITIVES171食品添加剂申请FOODADDITIVEPETITIONS172允许直接加入用于人类消费食品的食品添加剂FOODADDITIVESPERMITTEDFORDIRECTADDITIONTOFOODFORHUMANCONSUMPTION173在用于人类消费的食品中允许的次直接的食品添加剂SECONDARYDIRECTFOODADDITIVESPERMITTEDINFOODFORHUMANCONSUMPTION174间接食品添加剂：总则INDIRECTFOODADDITIVES:GENERAL175间接食品添加剂：胶粘剂与涂层的组分INDIRECTFOODADDITIVES:ADHESIVESANDCOMPONENTSOFCOATINGS176间接食品添加剂：纸与纸板组分INDIRECTFOODADDITIVES:PAPERANDPAPERBOARDCOMPONENTS177间接食品添加剂：聚合体INDIRECTFOODADDITIVES:POLYMERS178间接食品添加剂：辅剂、生产助剂和消毒剂INDIRECTFOODADDITIVES:ADJUVANTS,PRODUCTIONAIDS,ANDSANITIZERS179在食品生产、加工和处理中的辐照IRRADIATIONINTHEPRODUCTION,PROCESSINGANDHANDLINGOFFOOD180在额外试验期间临时在食品或者在与食品接触中被允许的食品添加剂FOODADDITIVESPERMITTEDINFOODORINCONTACTWITHFOODONANINTERIMBASISPENDINGADDITIONALSTUDY181先前核准的食品配料PRIOR-SANCTIONEDFOODINGREDIENTS182一般认为安全的物质SUBSTANCESGENERALLYRECOGNIZEDASSAFE184被确认为一般认为安全的直接食品物质DIRECTFOODSUBSTAN