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）
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 司法部强制执行局（Drug Enforcement Administration，Department of Justice）
Ⅲ 1400-1499 控制政策办公室（Office of National Drug Control Policy）
4 200-299
5 300-499
6 500-599
7 600-799
8 800-1299
9 Ⅱ 1300-1399 司法部强制执行局（Drug Enforcement Administration，Department of Justice）
Ⅲ 1400-1499 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 AD
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 AD
MINISTRATION
17 行政听证 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 NONCL
17 行政听证 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 NONCL
INICAL LABORATORY STUDIES
60 专利期恢复 PATENT TERM RESTORATION
70 素添加剂 COLOR ADDITIVES
71 素添加剂申请 COLOR ADDITIVE PETITIONS
73 免除认证的素添加剂的列表 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
74 适用认证的素添加剂的列表 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
80 素添加剂认证 COLOR ADDITIVE CERTIFICATION
81 用于食品、药品和化妆品的临时性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素和规范的列表 LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
83-98 [预留的] [Reserved]
60 专利期恢复 PATENT TERM RESTORATION
70 素添加剂 COLOR ADDITIVES
71 素添加剂申请 COLOR ADDITIVE PETITIONS
73 免除认证的素添加剂的列表 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
74 适用认证的素添加剂的列表 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
80 素添加剂认证 COLOR ADDITIVE CERTIFICATION
81 用于食品、药品和化妆品的临时性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
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
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 MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS
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
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, AN
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, AN
D 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
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 ADDITIVE
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 ADDITIVE
S 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]
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
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 药品现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
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 药品现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
216 药房配药 PHARMACY COMPOUNDING
225 含药饲料的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
226 含A类药品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
250 特殊人用药品的特殊要求 SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
290 管制药品 CONTROLLED DRUGS
299 药品；正式名称与已确定的名称 DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES
225 含药饲料的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
226 含A类药品的现行良好制造规范 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
250 特殊人用药品的特殊要求 SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
290 管制药品 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 FDA批准上市新药的申请 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW
300 总则 GENERAL
310 新药 NEW DRUGS
312 试验用新药申请 INVESTIGATIONAL NEW DRUG APPLICATION
314 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
美国保健品排行榜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 一般认为安全有效以及不错贴标签的非处方人用药品 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
331 非处方人用抗酸产品 ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
332 非处方人用抗胃肠气胀产品 ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
333 非处方人用局部抗菌药品 TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-
315 诊断用放射品 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
美国保健品排行榜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 一般认为安全有效以及不错贴标签的非处方人用药品 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
331 非处方人用抗酸产品 ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
332 非处方人用抗胃肠气胀产品 ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
333 非处方人用局部抗菌药品 TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-
THE-COUNTER HUMAN USE
335 非处方人用止泻药品 ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
336 非处方人用止吐药品 ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
338 非处方人用助睡眠药品 NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
340 非处方人用兴奋药品 STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
341 非处方人用的感冒、咳嗽、过敏症药、支气管扩张以及平喘药品 COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
343 非处方人用内服止痛、退热以及抗风湿药品 INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
344 非处方人用局部耳部药品 TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUN
335 非处方人用止泻药品 ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
336 非处方人用止吐药品 ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
338 非处方人用助睡眠药品 NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
340 非处方人用兴奋药品 STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
341 非处方人用的感冒、咳嗽、过敏症药、支气管扩张以及平喘药品 COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
343 非处方人用内服止痛、退热以及抗风湿药品 INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
344 非处方人用局部耳部药品 TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUN
TER HUMAN USE
346 非处方人用肛肠药品 ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
347 非处方人用皮肤保护药品 SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
348 非处方人用外用止痛药品 EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
349 非处方人用眼科药品 OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
350 非处方人用止汗药品 ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
352非处方人用防晒药品 SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]
355 非处方人用防龋药品 ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
346 非处方人用肛肠药品 ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
347 非处方人用皮肤保护药品 SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
348 非处方人用外用止痛药品 EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
349 非处方人用眼科药品 OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
350 非处方人用止汗药品 ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
352非处方人用防晒药品 SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]
355 非处方人用防龋药品 ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
357 非处方人用其他内服药品 MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
358非处人用的其他外用药品 MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
361 一般认为安全与有效以及不错贴标签的处方人用药品：用于研究的药品 PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
369 在非处方销售药品与器械上关于警告解释性声明 INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
370-499 [预留的] [Reserved]
358非处人用的其他外用药品 MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
361 一般认为安全与有效以及不错贴标签的处方人用药品：用于研究的药品 PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
369 在非处方销售药品与器械上关于警告解释性声明 INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
370-499 [预留的] [Reserved]
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