-
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》（
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（
Chapte
r
）、
1499
部（
< br>Parts
）。
其中：第
1
―
8
卷第
1
章第
1
―
1299<
/p>
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
< br>9
卷第
2
章第
< br>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<
/p>
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（<
/p>
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”（
T
itle 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
―
G
ENERAL
）
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
F
DA
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 <
/p>
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<
/p>
B
分章―用于人类消费的食品（
SUBC
HAPTER 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
< br>水果黄油、
果冻、
防腐剂以及相关产品
< br>
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
处方药的药物治疗指导
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
第
D
分章―人用药品（
SUBCHAPTER
D
―
DRUGS FOR HUMAN
USE
）
300
总则
GENERAL
310
新药
NEW DRUGS
312
试验用新药申请
INVESTIGATIONAL NEW DRUG APPLICATION
314
为
FDA
批准上市新药的申请
APPLICATIONS FOR FDA APPROVAL TO MARKET
A NEW DRUG
315
诊断用放射性药品
DIAGNOSTIC RADIOPHARMACEUTICALS
316
罕见病药
ORPHAN DRUGS
320
生物利用度与生物等效性要求
BIOAVAILABILITY AND BIOEQUIVALENCE
REQUIREMENTS
328
含有酒精的预期用于口部摄入的非处方药品
OVER-THE-COUNTER DRUG PRODUCTS INTENDED
FOR ORAL
INGESTION THAT CONTAIN ALCOHOL
330
一般认为安全与有效以及不错误标识的非处方人用药品
OVER-THE-COUNTER (OTC) HUMAN DRUGS
WHICH ARE GENERALLY RECOGNIZED AS SAFE
AND EFFECTIVE AND NOT MISBRANDED
331
用于非处方的人类使用的抗酸产品
ANTACID PRODUCTS FOR OVER-THE-COUNTER
(OTC) HUMAN USE
332
用于非处方的人类使用的抗胃肠气胀产品
ANTIFLATULENT PRODUCTS FOR OVER-THE-
COUNTER
HUMAN USE
333
用于非处方的人类使用的局部抗菌药品
TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR
OVER-THE-COUNTER HUMAN USE
335
用于非处方的人类使用的止泻药品
ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-
THE-COUNTER
HUMAN USE
336
用于非处方的人类使用的止吐药品
ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-
COUNTER HUMAN
USE
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