美国联邦法规CFR第篇“食品与药品”总目录

更新时间:2023-07-02 06:48:30 阅读: 评论:0

美国联邦法规(CFR)第21篇“食品与药品”总目录
概述:《美国联邦法规》(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,为司法部毒品强制执行局(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)的概况
卷(Volume) 章(Chapter)部(Parts) 规制机关(Regulatory Entity)?
朴实近义词
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 司法部毒品强制执行局(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 一般强制执行规章 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 强制执行政策 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?下吏
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 空腹跳绳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] [Rerved]?蜜蜂的图片
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
111保健品(膳食补充剂)GMP要求CURRENT GOOD 白酒起源>醒怎么写MANUFACTURING PRACTIC
E IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS地球表层
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 存在显着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 WATE
R ?

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