美國《聯邦規章典集》（CFR）第21篇“食(shi)品(pin)與藥(yao)品(pin)”總目
概述：美國(guo)《聯邦(bang)規(gui)章(zhang)典集》（Code of Federal Regulations，CFR）第21篇(pian)“食品與(yu)藥品”（Title 21―Food and Drugs）共有9卷（Volume）、3章(zhang)（Chapter）、1499部（Parts）。其中：第1―8卷第1章第1―1299部，為健康(kang)與人類服(fu)務(wu)部食品(pin)與藥品(pin)管理(li)局（Food and Drug Administration，Department of Health and Human Services）的規章；第9卷第(di)2章第1300―1399部，為司法部毒品強(qiang)制執行局（Drug Enforcement Administration，Department of Justice）的(de)規(gui)章(zhang)；第9卷(juan)第(di)3章第1400―1499部，為毒(du)品控(kong)制政策辦(ban)公室（Office of National Drug Control Policy）的(de)規(gui)章。
第21篇“食品與藥品”（Title 21―Food and Drugs）的概況(kuang)
卷（Volume） 章（Chapter） 部（Parts） 規(gui)制(zhi)機關（Regulatory Entity）
1 Ⅰ 1-99 健康與人類服務(wu)部食(shi)品(pin)與藥(yao)品(pin)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(pin)強(qiang)制執行局（Drug Enforcement Administration，Department of Justice）
Ⅲ 1400-1499 毒品(pin)控制政策(ce)辦(ban)公室(shi)（Office of National Drug Control Policy）
第21篇“食品與(yu)藥品”（Title 21―Food and Drugs）的(de)章、部(bu)目錄
部(Part) 中(zhong)譯文(wen) 原英文(wen)
第Ⅰ章―健康與人類服務部食(shi)品與藥(yao)品管理局（CHAPTER Ⅰ―FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）
第A分章(zhang)―總則（SUBCHAPTER A―GENERAL）
1 一(yi)般強制(zhi)執行規章(zhang) GENERAL ENFORCEMENT REGULATIONS
2 一般行政規則與決定(ding) GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
3 產品管轄權 PRODUCT JURISDICTION
5 組(zu)織(zhi) ORGANIZATION
7 強制執行政策(ce) ENFORCEMENT POLICY
10 行(xing)政(zheng)規范與程序 ADMINISTRATIVE PRACTICES AND PROCEDURES
11 電(dian)子(zi)(zi)化記錄；電(dian)子(zi)(zi)化簽名(ming) ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
12 正式(shi)證(zheng)據的(de)公眾(zhong)聽證(zheng) FORMAL EVIDENTIARY PUBLIC HEARING
13 在(zai)公眾質(zhi)詢委員(yuan)會前(qian)的公眾聽(ting)證 PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
14 在公眾咨詢委員(yuan)會(hui)前的公眾聽證 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
15 在(zai)FDA局長前的(de)公(gong)眾(zhong)聽證 PUBLIC HEARING BEFORE THE COMMISSIONER
16 在FDA前的規制性聽證(zheng) REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
17 行(xing)政(zheng)罰款(kuan)聽(ting)證 CIVIL MONEY PENALTIES HEARINGS
19 行為標準與利益沖突 STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
20 公共信息 PUBLIC INFORMATION
21 隱(yin)私(si)保護 PROTECTION OF PRIVACY
25 環境(jing)影響考慮 ENVIRONMENTAL IMPACT CONSIDERATIONS
26 藥品(pin)良好制造規范報(bao)告、醫療(liao)器(qi)械質量體(ti)系(xi)核(he)查報(bao)告以及(ji)某些醫療(liao)器(qi)械產品(pin)評價報(bao)告的互認(ren)：美國與歐共體(ti) 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 人類受(shou)試者的保護 PROTECTION OF HUMAN SUBJECTS
54 臨床試驗者的財務公開 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
56 機構審查委員(yuan)會 INSTITUTIONAL REVIEW BOARDS
58 對非(fei)臨床(chuang)實驗室研究的(de)良好(hao)實驗室規范 GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY ;STUDIES
60 專利期恢復 PATENT TERM RESTORATION
70 色素添加劑(ji) COLOR ADDITIVES
71 色素添(tian)加(jia)劑申請 COLOR ADDITIVE PETITIONS
73 免除認證的色素添加劑(ji)的列表 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
74 適用(yong)認證的(de)色素添加劑(ji)的(de)列表 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
80 色素添加劑認證(zheng) COLOR ADDITIVE CERTIFICATION
81 用于食品(pin)、藥品(pin)和(he)化妝品(pin)的(de)臨時性色素添(tian)加劑的(de)一般(ban)規范和(he)一般(ban)限制(zhi) GENERAL SPECIFICATIONS AND GENERAL RESTRICTIONS FOR PROVISIONAL COLOR ADDITIVES FOR USE IN FOODS, DRUGS, AND COSMETICS
82 經認證的(de)(de)臨時性列表的(de)(de)色素和規范的(de)(de)列表 LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
83-98 [預留的] [Reserved]
99 已上市的(de)藥品(pin)、生物制(zhi)品(pin)和器械的(de)未(wei)經批(pi)準的(de)/新的(de)用途的(de)信息的(de)發布 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
第B分章―用于人類消費(fei)的食品（SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION）
100 總則(ze) GENERAL
101 食品標(biao)識(shi) FOOD LABELING
102 非標準化食品的(de)普通的(de)或者通常的(de)名稱 COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS
104 食(shi)品的(de)營養(yang)質量(liang)指(zhi)南 NUTRITIONAL QUALITY GUIDELINES FOR FOODS
105 特(te)殊膳食(shi)用(yong)途(tu)的食(shi)品 FOODS FOR SPECIAL DIETARY USE
106 嬰兒配(pei)方母乳替代食品質量控制程(cheng)序 INFANT FORMULA QUALITY CONTROL PROCEDURES
107 嬰兒配方(fang)母乳(ru)替代食品 INFANT FORMULA
108 緊急許可控制 EMERGENCY PERMIT CONTROL
109 在人類食(shi)品與食(shi)品-包裝材料中的(de)不可避免的(de)污染物(wu) UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL
110 在制(zhi)造(zao)、包裝或者保(bao)存人類食品中的現行(xing)良好制(zhi)造(zao)規范(fan) CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
113 裝在密封容器中的熱(re)加工(gong)低酸食品 THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS
114 酸(suan)化食品(pin) ACIDIFIED FOODS
115 帶殼蛋 SHELL EGGS
119 存(cun)在(zai)顯著或者不合理風險(xian)的膳(shan)食補(bu)充劑 DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK
120 危害(hai)分析與(yu)關鍵控制點（HACCP）體系 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
123 魚(yu)與漁業產品 FISH AND FISHERY PRODUCTS
129 飲(yin)用水加工(gong)與裝瓶 PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER
130 食品標準：總則 FOOD STANDARDS: GENERAL
131 乳與奶油 MILK AND CREAM
133 乳(ru)(ru)酪(lao)與相關乳(ru)(ru)酪(lao)產(chan)品 CHEESES AND RELATED CHEESE PRODUCTS
135 冷凍(dong)點心 FROZEN DESSERTS
136 烘焙產品 BAKERY PRODUCTS
137 谷物粉(fen)與(yu)相關產品 CEREAL FLOURS AND RELATED PRODUCTS
139 通心粉(fen)與面(mian)條(tiao)產品 MACARONI AND NOODLE PRODUCTS
145 罐裝水果 CANNED FRUITS
146 罐裝水果汁 CANNED FRUIT JUICES
150 水果黃油、果凍、防(fang)腐劑以及相關(guan)產品(pin) FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS
152 水果餡餅 FRUIT PIES
155 罐裝(zhuang)蔬(shu)菜 CANNED VEGETABLES
156 蔬菜汁 VEGETABLE JUICES
158 冷凍蔬(shu)菜 FROZEN VEGETABLES
160 蛋(dan)(dan)與蛋(dan)(dan)制品 EGGS AND EGG PRODUCTS
161 魚與(yu)有殼的水生動物 FISH AND SHELLFISH
163 可(ke)可(ke)制品 CACAO PRODUCTS
164 樹(shu)堅果與花生制(zhi)品 TREE NUT AND PEANUT PRODUCTS
165 飲料 BEVERAGES
166 人(ren)造(zao)黃油 MARGARINE
168 增甜劑(ji)與餐桌糖漿 SWEETENERS AND TABLE SIRUPS
169 食品敷(fu)料(liao)與調味(wei)料(liao) FOOD DRESSINGS AND FLAVORINGS
170 食品添加劑 FOOD ADDITIVES
171 食品添加(jia)劑(ji)申請(qing) FOOD ADDITIVE PETITIONS
172 允許(xu)直(zhi)接(jie)加入用于(yu)人類消費食品(pin)的食品(pin)添加劑 FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN ;CONSUMPTION
173 在用于人類消費的(de)食品中允許(xu)的(de)次(ci)直接的(de)食品添加劑 SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
174 間(jian)接(jie)食(shi)品添加劑：總則 INDIRECT FOOD ADDITIVES: GENERAL
175 間(jian)接食品添(tian)加劑：膠粘劑與涂層的組分 INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS
176 間(jian)接食(shi)品添加劑：紙與紙板(ban)組分 INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
177 間(jian)接食品(pin)添加劑：聚(ju)合體 INDIRECT FOOD ADDITIVES: POLYMERS
178 間接食品添加劑(ji)：輔(fu)劑(ji)、生產(chan)助劑(ji)和消毒劑(ji) INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
179 在食(shi)品生產、加工和處理中的輻照(zhao) IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD
180 在額(e)外試(shi)驗(yan)期(qi)間臨(lin)時在食(shi)品或者在與食(shi)品接觸(chu)中被允(yun)許(xu)的食(shi)品添加劑 FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ;ON AN INTERIM BASIS PENDING ADDITIONAL STUDY
181 先前(qian)核準的食品(pin)配(pei)料 PRIOR-SANCTIONED FOOD INGREDIENTS ;
182 一般認為安全的(de)物質 SUBSTANCES GENERALLY RECOGNIZED AS SAFE
184 被確(que)認(ren)為(wei)一般認(ren)為(wei)安全的直接食(shi)品物質(zhi) DIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
186 被確認為一般認為安全的(de)間接食品物(wu)質 INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
189 禁(jin)止用于人(ren)類食品(pin)的(de)物質(zhi) SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
190 膳食補充劑(ji) DIETARY SUPPLEMENTS
191-199 [預(yu)留的] [Reserved]
第C分章―藥品：總則（SUBCHAPTER C―DRUGS: GENERAL）
200 總則(ze) GENERAL
201 標(biao)識 LABELING
202 處方藥廣告 PRESCRIPTION DRUG ADVERTISING
203 處方藥銷售 PRESCRIPTION DRUG MARKETING
205 對批發(fa)處方藥銷(xiao)售商頒發(fa)州(zhou)執(zhi)照的指南 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS
206 人(ren)用固體口服(fu)劑型藥品的印碼 IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE
207 藥品生產(chan)者的登記與商業銷售的藥品的列表 REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION
208 處方藥的藥物治療指(zhi)導 MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS
210 制造(zao)、加工、包(bao)裝或者保(bao)存(cun)藥品的現(xian)行良好制造(zao)規范；總則 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
211 對完(wan)成的藥(yao)品的現行(xing)良好(hao)制(zhi)造(zao)規范 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS
216 藥房配藥 PHARMACY COMPOUNDING
225 對(dui)含(han)藥飼(si)料的(de)現(xian)行良好制造規范 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
226 對A型含(han)藥物(wu)品(pin)的現行良好制(zhi)造規范 CURRENT GOOD MANUFACTURING PRACTICE FOR ;TYPE A MEDICATED ARTICLES
250 對特(te)殊(shu)人用藥品的特(te)殊(shu)要求 SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
290 管制的藥品 CONTROLLED DRUGS
299 藥(yao)品；正式名稱與已確定的(de)名稱 DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES ;
第D分章(zhang)―人用(yong)藥品(pin)（SUBCHAPTER D―DRUGS FOR HUMAN USE）
300 總(zong)則(ze) GENERAL
310 新藥 NEW DRUGS
312 試驗用新藥(yao)申請 INVESTIGATIONAL NEW DRUG APPLICATION
314 為FDA批準上(shang)市(shi)新藥的(de)申請 APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG ;
315 診斷用放射性藥品 DIAGNOSTIC RADIOPHARMACEUTICALS
316 罕見病(bing)藥 ORPHAN DRUGS
320 生物利用度與生物等效性要求 BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
328 含(han)有酒精(jing)的預期(qi)用于口部攝入(ru)的非處方藥品(pin) OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ;ORAL INGESTION THAT CONTAIN ALCOHOL
330 一般認為(wei)安全(quan)與有效以及不錯誤標識的非處(chu)方(fang)人(ren)用藥(yao)品 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
331 用于非處方的(de)人類使(shi)用的(de)抗酸產品(pin) ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
332 用(yong)于非處(chu)方的人類使用(yong)的抗胃腸氣脹產(chan)品 ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
333 用于非(fei)處方(fang)的(de)人類使用的(de)局部抗菌藥品(pin) TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
335 用(yong)于非處方的人類(lei)使用(yong)的止瀉藥(yao)品 ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
336 用(yong)于非處方(fang)的人類使(shi)用(yong)的止吐藥品(pin) ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
338 用(yong)于非處(chu)方的(de)人(ren)類使用(yong)的(de)幫(bang)助夜間睡眠的(de)藥(yao)品(pin) NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
340 用(yong)于非(fei)處方的人類使用(yong)的興奮(fen)藥品 STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
341 用于(yu)非處方的人(ren)類使(shi)用的感(gan)冒、咳嗽、過(guo)敏癥(zheng)藥、支氣管擴張(zhang)以及(ji)平喘(chuan)藥品 COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
343 用于非處方的(de)人類使用的(de)內服的(de)止痛、退(tui)熱以及抗風濕藥品 INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
344 用于非處方的(de)人類使用的(de)局部的(de)耳部藥品 TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
346 用于非處(chu)方的人類使用的肛腸藥品 ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
347 用于非處方的人類使用的皮(pi)膚保護藥品 SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
348 用于非處方(fang)的(de)(de)(de)人類使用的(de)(de)(de)外部的(de)(de)(de)止痛藥(yao)品(pin) EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
349 用(yong)于非處(chu)方的人類使用(yong)的眼科藥(yao)品(pin) OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
350 用于非處方的人(ren)類使用的止汗藥(yao)品 ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
352 用(yong)于(yu)非處(chu)方的人類使用(yong)的遮光藥品 SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]
355 用于(yu)非處方的(de)人類(lei)使(shi)用的(de)防齲藥品 ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
357 用于非處方的人類使用的其他內服藥品 MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
358 用(yong)于非處方的人類使用(yong)的其(qi)他外用(yong)藥品(pin) MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
361 一般認為安全與(yu)有(you)效以及不錯誤標(biao)識的(de)處方人用(yong)藥品：用(yong)于研究的(de)藥品 PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
369 在用于非處方(fang)銷(xiao)售的藥品與器(qi)械上關于警告的解釋性聲明 INTERPRETATIVE ;STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
370-499 [預留(liu)的] [Reserved]
第E分章(zhang)―動物藥(yao)品、飲料和相(xiang)關(guan)產品（SUBCHAPTER E―ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS）
500 總則(ze) GENERAL
501 動物(wu)食品標識 ANIMAL FOOD LABELING
502 非標(biao)準化的(de)(de)(de)動物(wu)食品的(de)(de)(de)普通的(de)(de)(de)或通常的(de)(de)(de)名稱 COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS
509 在動(dong)物食(shi)品與(yu)食(shi)品-包裝材(cai)料中的(de)不(bu)可避免的(de)污染物 UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL
510 新動(dong)物藥(yao) NEW ANIMAL DRUGS
511 作為(wei)試驗(yan)用途的(de)新(xin)動(dong)物藥 NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
514 新動物(wu)藥申請(qing) NEW ANIMAL DRUG APPLICATIONS
515 含藥飼(si)料廠執照(zhao) MEDICATED FEED MILL LICENSE
520 口服劑型的新動物藥 ORAL DOSAGE ;FORM NEW ANIMAL DRUGS
522 植(zhi)入或者注射劑型的新動物藥 IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
524 眼(yan)科(ke)和局部劑型的新動(dong)物藥(yao) OPHTHALMIC AND TOPICAL DOSAGE FORM ;NEW ANIMAL DRUGS
526 乳房內的劑型 INTRAMAMMARY DOSAGE FORMS
529 某些其他(ta)劑(ji)型(xing)的(de)新(xin)動物藥 CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
530 在動物中的(de)特別標簽(qian)藥(yao)品使用 EXTRALABEL DRUG USE IN ;ANIMALS
556 在食品(pin)中新動(dong)物藥殘留的(de)容(rong)許量 TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD
558 用于(yu)動(dong)物飼料的新動(dong)物藥(yao) NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
564 [預(yu)留的] [Reserved]
570 食品添加劑 FOOD ADDITIVES
571 食(shi)品添加(jia)劑申(shen)請 FOOD ADDITIVE PETITIONS
573 在(zai)動物飼料與飲(yin)用水中允許的食品添(tian)加劑 FOOD ADDITIVES ;PERMITTED IN FEED AND DRINKING WATER OF ANIMALS
579 在(zai)動物飼料和寵物食(shi)品的生產、加工和處理中的輻照 IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD
582 一般認為安(an)全的(de)物質 SUBSTANCES GENERALLY RECOGNIZED AS SAFE
584 在動物飼料(liao)與飲用(yong)水中(zhong)被確認為一般認為安(an)全的食品物質 FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS
589 禁止用于動物食品或者飼料的物質 SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
590-599 [預留(liu)的] [Reserved]
第F分章(zhang)―生物制品(pin)（SUBCHAPTER F―BIOLOGICS）
600 生物制(zhi)品：總則(ze) BIOLOGICAL PRODUCTS: GENERAL
601 頒發執照 LICENSING
606 對血液與血液組(zu)分的現行良好制造規范 CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
607 對人類血液(ye)與(yu)(yu)血液(ye)制品的制造者(zhe)的機構登記與(yu)(yu)產品列表 ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR ;MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
610 普通(tong)生物制品標準 GENERAL BIOLOGICAL PRODUCTS STANDARDS
630 對(dui)血(xue)液、血(xue)液組(zu)分和血(xue)液衍生物的一般要求 GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES
640 對人類血(xue)液和(he)血(xue)液制品的附加(jia)標準(zhun) ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD ;PRODUCTS
660 對用(yong)于實驗室檢測(ce)的診斷(duan)物質(zhi)的附加標準 ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
680 對其(qi)他產品(pin)的附(fu)加標準(zhun) ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS
第G分章―化妝品（SUBCHAPTER G―COSMETICS）
700 總則 GENERAL
701 化妝品標識 COSMETIC LABELING
710 化妝品(pin)機構的(de)自愿登記(ji) VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS
720 化妝品配(pei)料構成聲明的自愿存檔 VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS
740 化妝品(pin)警告聲明 COSMETIC PRODUCT WARNING STATEMENTS
741-799 [預留(liu)的] [Reserved]
第H分章―醫療器(qi)械（SUBCHAPTER H―MEDICAL DEVICES）
800 總則 GENERAL
801 標識 LABELING
803 醫療器械報告 MEDICAL DEVICE REPORTING
806 醫療器械；改正(zheng)與移動的報告(gao) MEDICAL DEVICES; ;REPORTS OF CORRECTIONS AND REMOVALS
807 對器械的制造者(zhe)(zhe)與首次(ci)進口者(zhe)(zhe)的機(ji)構登(deng)記與器械列(lie)表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
808 對州和地方醫療器械要求的聯邦優(you)先權(quan)的豁免(mian) EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
809 人用(yong)體外(wai)診(zhen)斷產品 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
810 醫療(liao)器械(xie)召回(hui)權 MEDICAL DEVICE RECALL AUTHORITY
812 試(shi)驗用器械(xie)豁免 INVESTIGATIONAL DEVICE EXEMPTIONS
813 [預留的] [Reserved]
814 醫(yi)療器械的上市前(qian)批(pi)準 PREMARKET APPROVAL OF MEDICAL DEVICES
820 質量體系規章 QUALITY SYSTEM REGULATION
821 醫療器械跟蹤要求 MEDICAL DEVICE TRACKING REQUIREMENTS
822 上市后監視 POSTMARKET SURVEILLANCE
860 醫療器械分類程序(xu) MEDICAL DEVICE CLASSIFICATION PROCEDURES
861 性能標準制定程(cheng)序 PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
862 臨床化學與臨床毒理(li)學器械 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
864 血液(ye)學(xue)與病(bing)理學(xue)器械 HEMATOLOGY AND PATHOLOGY DEVICES
866 免疫(yi)學與微(wei)生物(wu)學器(qi)械 IMMUNOLOGY AND MICROBIOLOGY DEVICES
868 麻醉(zui)學器械 ANESTHESIOLOGY DEVICES
870 心血(xue)管(guan)器(qi)械 CARDIOVASCULAR DEVICES
872 牙科器械(xie) DENTAL DEVICES
874 耳、鼻(bi)和咽器械 EAR, NOSE, AND THROAT DEVICES ;
876 胃腸病學-泌尿(niao)學器(qi)械 GASTROENTEROLOGY-UROLOGY DEVICES
878 普通(tong)與整形外科器(qi)械 GENERAL AND PLASTIC SURGERY DEVICES
880 普通(tong)醫院與個人使用器械 GENERAL HOSPITAL AND PERSONAL USE DEVICES
882 神經學器械 NEUROLOGICAL DEVICES
884 產科(ke)與婦科(ke)學器械 OBSTETRICAL AND GYNECOLOGICAL DEVICES
886 眼(yan)科器械 OPHTHALMIC DEVICES
888 矯形外(wai)科器械 ORTHOPEDIC DEVICES
890 內科學器(qi)械 PHYSICAL MEDICINE DEVICES
892 放射學器械 RADIOLOGY DEVICES
895 禁(jin)止的器械 BANNED DEVICES
898 電(dian)極鉛線(xian)與(yu)患者電(dian)纜的性能標準(zhun) PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES
第I分章―乳(ru)房造(zao)影質量標準法(fa)（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDARDS ACT）
900 乳房造影法(fa) MAMMOGRAPHY
第J分章―放射學的健康（SUBCHAPTER J―RADIOLOGICAL HEALTH）
1000 總則 GENERAL
1002 記錄與報告(gao) RECORDS AND REPORTS
1003 缺陷與未能守(shou)法的通報 NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
1004 電子(zi)產品的回(hui)購、修理或者置(zhi)換 REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS
1005 電(dian)子產品的進口 IMPORTATION OF ELECTRONIC PRODUCTS
1010 電子(zi)產品的性能標準(zhun)：總則(ze) PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
1020 電離輻(fu)射發生(sheng)產(chan)品的(de)性(xing)能(neng)標(biao)準 PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
1030 微(wei)波與射(she)電頻率發生(sheng)產品的性能標準 PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS
1040 發(fa)光產品的(de)性能標準 PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
1050 聲波、次(ci)聲波和超聲波發生產品的(de)性能標準 PERFORMANCE ;STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS
第K分章―[預留的(de)]（SUBCHAPTER K―[RESERVED]）
第L分章―根(gen)據由食(shi)品與藥品管理局行政執行的(de)某(mou)些其他法的(de)規章(zhang)（SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE ;FOOD AND DRUG ADMINISTRATION）
1210 根據(ju)《聯邦(bang)進口乳法》的(de)規章 REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT
1230 根據《聯邦腐蝕性毒物(wu)法》的規(gui)章 REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT
1240 傳染病的控(kong)制 CONTROL OF COMMUNICABLE DISEASES
1250 州際運輸衛生 INTERSTATE CONVEYANCE SANITATION
1251-1269 [預留(liu)的] [Reserved]
1270 預期用于(yu)移植的(de)人體組(zu)織 HUMAN TISSUE INTENDED FOR TRANSPLANTATION
1271 人體(ti)細胞(bao)、組(zu)織以(yi)及細胞(bao)的和基于組(zu)織的產(chan)品 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
1272-1299 [預留的] [Reserved]
第Ⅱ章―司法部(bu)毒(du)品強制執行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）
1300 定(ding)義 DEFINITIONS
1301 管制物(wu)質的制造者、分銷(xiao)者和調劑者的登記 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
1302 對管制物(wu)質的標識與包裝要(yao)求 LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES
1303 定額 QUOTAS
1304 登記者的(de)記錄與報告 RECORDS AND REPORTS OF REGISTRANTS
1305 令(ling)的格(ge)式 ORDER FORMS
1306 處方(fang) PRESCRIPTIONS
1307 雜項 MISCELLANEOUS
1308 管(guan)制(zhi)物(wu)質(zhi)的(de)表 SCHEDULES OF CONTROLLED SUBSTANCES
1309 表I化學(xue)品的制造者、分銷者、進(jin)口(kou)(kou)者和出(chu)口(kou)(kou)者的登(deng)記(ji) REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS
1310 列入(ru)表的(de)化學品和某些機器的(de)記(ji)錄(lu)與報(bao)告 RECORDS AND REPORTS OF LISTED CHEMICALS AND ;CERTAIN MACHINES
1311 [預留(liu)的(de)] [Reserved]
1312 管制物質的進口(kou)(kou)與出(chu)口(kou)(kou) IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES
1313 前體(ti)與(yu)必要化(hua)學品的(de)進口與(yu)出口 IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS
1314-1315 [預留的] [Reserved]
1316 行(xing)政(zheng)職能(neng)、規范和(he)程序 ADMINISTRATIVE ;FUNCTIONS, PRACTICES, AND PROCEDURES
第Ⅲ章―毒品(pin)控制政(zheng)策辦公室（CHAPTER Ⅲ―Office of National Drug Control Policy）
1400 [預留的(de)] [Reserved]
1401 信息的公眾可(ke)及(ji)性 PUBLIC AVAILABILITY OF INFORMATION
1402 強制(zhi)性(xing)解密(mi)審查(cha) MANDATORY DECLASSIFICATION REVIEW
1403 對給予州和地方政(zheng)(zheng)府資金(jin)和合作協議的統一行政(zheng)(zheng)要求(qiu) UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS
1404 政府范圍的排除與暫(zan)停(ting)（非獲得） GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)
1405 對無毒品(pin)工作場所的(de)政(zheng)府范圍(wei)的(de)要(yao)求（財政(zheng)援助） GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)&nbs
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