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美国FDA《联邦规章典集》(CFR)第21篇目录中文版(一)

阅读: 2016年11月14日

美国FDA《联邦规章典集》(CFR)第21篇目录中文版(一)

 

  美国《联邦规章典集》(CFR)第21篇“食品与药品”总目

  概述:美国《联邦规章典集》(Code of Federal Regulations,CFR)第21篇“食品与药品”(Title 21―Food and Drugs)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(Food and Drug Administration,Department of Health and Human Services)的规章;第9卷第2章第1300―1399部,为司法部毒品强制实行局(Drug Enforcement Administration,Department of Justice)的规章;第9卷第3章第1400―1499部,为毒品控制政策办公室(Office of National Drug Control Policy)的规章。

  第21篇“食品与药品”(Title 21―Food and Drugs)的概述

  卷(Volume) 章(Chapter) 部(Parts) 规制机关(Regulatory Entity)

  1 Ⅰ 1-99 健康与人类服务部食品与药品管理局(FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES)

  2 100-169

  3 170-199

  4 200-299

  5 300-499

  6 500-599

  7 600-799

  8 800-1299

  9 Ⅱ 1300-1399 司法部毒品强制实行局(Drug Enforcement Administration,Department of Justice)

  Ⅲ 1400-1499 毒品控制政策办公室(Office of National Drug Control Policy)

  第21篇“食品与药品”(Title 21―Food and Drugs)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(CHAPTER Ⅰ―FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES)

  第A分章―总则(SUBCHAPTER A―GENERAL)

  1 一般强制实行规章 GENERAL ENFORCEMENT REGULATIONS

  2 一般行政规则与决定 GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

  3 产品管辖权 PRODUCT JURISDICTION

  5 组织 ORGANIZATION

  7 强制实行政策 ENFORCEMENT POLICY

  10 行政规范与程序 ADMINISTRATIVE PRACTICES AND PROCEDURES

  11 电子化记录;电子化签名 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

  12 正式证据的公众听证 FORMAL EVIDENTIARY PUBLIC HEARING

  13 在公众质询委员会前的公众听证 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

  14 在公众咨询委员会前的公众听证 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

  15 在FDA局长前的公众听证 PUBLIC HEARING BEFORE THE COMMISSIONER

  16 在FDA前的规制性听证 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

  17 行政罚款听证 CIVIL MONEY PENALTIES HEARINGS

  19 行为标准与利益冲突 STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST

  20 公共信息 PUBLIC INFORMATION

  21 隐私保护 PROTECTION OF PRIVACY

  25 环境影响考虑 ENVIRONMENTAL IMPACT CONSIDERATIONS

  26 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 MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN MEDICAL DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY

  50 人类受试者的保护 PROTECTION OF HUMAN SUBJECTS

  54 临床试验者的财务公开 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

  56 机构审查委员会 INSTITUTIONAL REVIEW BOARDS

  58 对非临床实验室研究的良好实验室规范 GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

  60 专利期恢复 PATENT TERM RESTORATION

  70 色素添加剂 COLOR ADDITIVES

  71 色素添加剂申请 COLOR ADDITIVE PETITIONS

  73 免除认证的色素添加剂的列表 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

  74 适用认证的色素添加剂的列表 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION

  80 色素添加剂认证 COLOR ADDITIVE CERTIFICATION

  81 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 GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS

  82 经认证的临时性列表的色素和规范的列表 LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS

  83-98 [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 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES

  第B分章―用于人类消费的食品(SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION)

  100 总则 GENERAL

  101 食品标识 FOOD LABELING

  102 非标准化食品的普通的或者通常的名称 COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS

  104 食品的营养质量指南 NUTRITIONAL QUALITY GUIDELINES FOR FOODS

  105 特殊膳食用途的食品 FOODS FOR SPECIAL DIETARY USE

  106 婴儿配方母乳替代食品质量控制程序 INFANT FORMULA QUALITY CONTROL PROCEDURES

  107 婴儿配方母乳替代食品 INFANT FORMULA

  108 紧急许可控制 EMERGENCY PERMIT CONTROL

  109 在人类食品与食品-包装材料中的不可避免的污染物 UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL

  110 在制造、包装或者保存人类食品中的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD

  113 装在密封容器中的热加工低酸食品 THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS

  114 酸化食品 ACIDIFIED FOODS

  115 带壳蛋 SHELL EGGS

  119 存在显著或者不合理风险的膳食补充剂 DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK

  120 危害分析与关键控制点(HACCP)体系 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS

  123 鱼与渔业产品 FISH AND FISHERY PRODUCTS

  129 饮用水加工与装瓶 PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER

  130 食品标准:总则 FOOD STANDARDS: GENERAL

  131 乳与奶油 MILK AND CREAM

  133 乳酪与相关乳酪产品 CHEESES AND RELATED CHEESE PRODUCTS

  135 冷冻点心 FROZEN DESSERTS

  136 烘焙产品 BAKERY PRODUCTS

  137 谷物粉与相关产品 CEREAL FLOURS AND RELATED PRODUCTS

  139 通心粉与面条产品 MACARONI AND NOODLE PRODUCTS

  145 罐装水果 CANNED FRUITS

  146 罐装水果汁 CANNED FRUIT JUICES

  150 水果黄油、果冻、防腐剂以及相关产品 FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS

  152 水果馅饼 FRUIT PIES

  155 罐装蔬菜 CANNED VEGETABLES

  156 蔬菜汁 VEGETABLE JUICES

  158 冷冻蔬菜 FROZEN VEGETABLES

  160 蛋与蛋制品 EGGS AND EGG PRODUCTS

  161 鱼与有壳的水生动物 FISH AND SHELLFISH

  163 可可制品 CACAO PRODUCTS

  164 树坚果与花生制品 TREE NUT AND PEANUT PRODUCTS

  165 饮料 BEVERAGES

  166 人造黄油 MARGARINE

  168 增甜剂与餐桌糖浆 SWEETENERS AND TABLE SIRUPS

  169 食品敷料与调味料 FOOD DRESSINGS AND FLAVORINGS

  170 食品添加剂 FOOD ADDITIVES

  171 食品添加剂申请 FOOD ADDITIVE PETITIONS

  172 允许直接加入用于人类消费食品的食品添加剂 FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION

  173 在用于人类消费的食品中允许的次直接的食品添加剂 SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION

  174 间接食品添加剂:总则 INDIRECT FOOD ADDITIVES: GENERAL

  175 间接食品添加剂:胶粘剂与涂层的组分 INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS

  176 间接食品添加剂:纸与纸板组分 INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS

  177 间接食品添加剂:聚合体 INDIRECT FOOD ADDITIVES: POLYMERS

  178 间接食品添加剂:辅剂、生产助剂和消毒剂 INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS

  179 在食品生产、加工和处理中的辐照 IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD

  180 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 FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY

  181 先前核准的食品配料 PRIOR-SANCTIONED FOOD INGREDIENTS

  182 一般认为安全的物质 SUBSTANCES GENERALLY RECOGNIZED AS SAFE

  184 被确认为一般认为安全的直接食品物质 DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

  186 被确认为一般认为安全的间接食品物质 INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE

  189 禁止用于人类食品的物质 SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD

  190 膳食补充剂 DIETARY SUPPLEMENTS

  191-199 [预留的] [Reserved]

  第C分章―药品:总则(SUBCHAPTER C―DRUGS: GENERAL)

  200 总则 GENERAL

  201 标识 LABELING

  202 处方药广告 PRESCRIPTION DRUG ADVERTISING

  203 处方药销售 PRESCRIPTION DRUG MARKETING

  205 对批发处方药销售商颁发州执照的指南 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS

  206 人用固体口服剂型药品的印码 IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE

  207 药品生产者的登记与商业销售的药品的列表 REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION

  208 处方药的药物治疗引导 MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS

  210 制造、加工、包装或者保存药品的现行良好制造规范;总则 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL

  211 对完成的药品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS

  216 药房配药 PHARMACY COMPOUNDING

  225 对含药饲料的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS

  226 对A型含药物品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES

  250 对特殊人用药品的特殊要求 SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS

  290 管制的药品 CONTROLLED DRUGS

  299 药品;正式名称与已确定的名称 DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES




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