美國《聯邦規章典集》（CFR）第21篇“食(shi)品與藥品”總目(mu)
概述：美國《聯邦規章典集(ji)》（Code of Federal Regulations，CFR）第21篇“食品(pin)與(yu)藥品(pin)”（Title 21―Food and Drugs）共(gong)有(you)9卷（Volume）、3章（Chapter）、1499部（Parts）。其中(zhong)：第1―8卷第1章第1―1299部，為健(jian)康與人類服務(wu)部食(shi)品與藥品管理局(ju)（Food and Drug Administration，Department of Health and Human Services）的規章；第(di)9卷第2章第1300―1399部，為司法(fa)部毒品(pin)強(qiang)制執行局（Drug Enforcement Administration，Department of Justice）的規章；第9卷第3章第1400―1499部，為毒(du)品控(kong)制政(zheng)策辦(ban)公室（Office of National Drug Control Policy）的規章。
第21篇“食品與藥品”（Title 21―Food and Drugs）的概況
卷（Volume） 章（Chapter） 部(bu)（Parts） 規制機關（Regulatory Entity）
1 Ⅰ 1-99 健康與人類(lei)服務部食品與藥(yao)品管理局(ju)（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)強制執行(xing)局（Drug Enforcement Administration，Department of Justice）
Ⅲ 1400-1499 毒品控制(zhi)政(zheng)策辦公室(shi)（Office of National Drug Control Policy）
第21篇“食(shi)品(pin)與藥品(pin)”（Title 21―Food and Drugs）的(de)章、部(bu)目錄
部(Part) 中(zhong)譯文 原(yuan)英文
第Ⅰ章―健康與(yu)人類服(fu)務(wu)部食(shi)品與(yu)藥品管(guan)理局（CHAPTER Ⅰ―FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES）
第A分章―總則（SUBCHAPTER A―GENERAL）
1 一(yi)般強制執行規章 GENERAL ENFORCEMENT REGULATIONS
2 一般行(xing)政規則與決定(ding) GENERAL ADMINISTRATIVE RULINGS AND DECISIONS
3 產品管轄權 PRODUCT JURISDICTION
5 組織 ORGANIZATION
7 強(qiang)制執行政策 ENFORCEMENT POLICY
10 行政規范與程序 ADMINISTRATIVE PRACTICES AND PROCEDURES
11 電(dian)子化記錄；電(dian)子化簽名 ELECTRONIC RECORDS; ELECTRONIC SIGNATURES
12 正(zheng)式證據(ju)的公眾聽證 FORMAL EVIDENTIARY PUBLIC HEARING
13 在(zai)公(gong)眾質詢委(wei)員會前的公(gong)眾聽(ting)證(zheng) PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY
14 在公眾咨(zi)詢委員會前的(de)公眾聽證 PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE
15 在FDA局長前的公眾聽證 PUBLIC HEARING BEFORE THE COMMISSIONER
16 在FDA前的(de)規制性聽證 REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION
17 行政罰(fa)款(kuan)聽證(zheng) CIVIL MONEY PENALTIES HEARINGS
19 行為(wei)標準與利益沖(chong)突(tu) STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST
20 公共(gong)信息 PUBLIC INFORMATION
21 隱(yin)私保護(hu) PROTECTION OF PRIVACY
25 環境影響考慮 ENVIRONMENTAL ;IMPACT CONSIDERATIONS
26 藥品良(liang)好制造規范報(bao)告、醫療(liao)器(qi)械質量(liang)體(ti)系核(he)查報(bao)告以及(ji)某(mou)些醫療(liao)器(qi)械產品評價報(bao)告的互認：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 人類受試(shi)者的保護 PROTECTION OF HUMAN SUBJECTS
54 臨床(chuang)試驗(yan)者的財務公開 FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS
56 機構審查委員會 INSTITUTIONAL REVIEW BOARDS
58 對非臨床(chuang)實(shi)驗室研究(jiu)的良好(hao)實(shi)驗室規(gui)范 GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES
60 專利期恢復 PATENT TERM RESTORATION
70 色素添(tian)加劑 COLOR ADDITIVES
71 色素添加劑申請 COLOR ADDITIVE PETITIONS
73 免除認證的(de)色素(su)添(tian)加劑的(de)列(lie)表 LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION
74 適用認證的色素添(tian)加劑的列表 LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION
80 色素添加劑認證(zheng) COLOR ADDITIVE CERTIFICATION
81 用于食品、藥品和(he)化妝品的臨(lin)時性色素添加劑的一般規范和(he)一般限制 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(gui)范的(de)(de)列表 LISTING OF CERTIFIED PROVISIONALLY LISTED COLORS AND SPECIFICATIONS
83-98 [預留的] [Reserved]
99 已上市(shi)的藥品、生物制品和器械的未(wei)經批準的/新的用途的信息(xi)的發布 DISSEMINATION OF INFORMATION ON UNAPPROVED/NEW USES FOR MARKETED DRUGS, BIOLOGICS, AND DEVICES
第B分章―用于(yu)人類消費的食品（SUBCHAPTER B―FOOD FOR HUMAN CONSUMPTION）
100 總(zong)則 GENERAL
101 食品標(biao)識 FOOD LABELING
102 非標(biao)準(zhun)化(hua)食品的普通(tong)的或(huo)者通(tong)常(chang)的名(ming)稱 COMMON OR ;USUAL NAME FOR NONSTANDARDIZED FOODS
104 食品的營養質量指南 NUTRITIONAL QUALITY GUIDELINES FOR FOODS
105 特殊膳食用途的食品 FOODS FOR SPECIAL DIETARY USE
106 嬰兒配方母乳替代(dai)食(shi)品質量控(kong)制程序(xu) INFANT FORMULA QUALITY CONTROL PROCEDURES
107 嬰(ying)兒配方母乳替(ti)代食品(pin) INFANT FORMULA
108 緊急許(xu)可控制 EMERGENCY PERMIT CONTROL
109 在(zai)人類食品與食品-包裝(zhuang)材料中的不可避免的污(wu)染物 UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL
110 在制造(zao)、包裝或(huo)者保(bao)存人類食品中的現行良好制造(zao)規范 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING, OR HOLDING HUMAN FOOD
113 裝在密封(feng)容器(qi)中的(de)熱(re)加工低酸(suan)食品 THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS
114 酸(suan)化食品 ACIDIFIED FOODS
115 帶殼蛋 SHELL EGGS
119 存在顯著(zhu)或者不合理風險的膳食補(bu)充劑 DIETARY SUPPLEMENTS THAT PRESENT A SIGNIFICANT OR UNREASONABLE RISK
120 危害分析與關鍵控(kong)制點（HACCP）體系 HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS
123 魚與漁業產品 FISH AND FISHERY PRODUCTS
129 飲用水加工與裝瓶 PROCESSING AND BOTTLING ;OF BOTTLED DRINKING WATER
130 食品標(biao)準：總(zong)則 FOOD ;STANDARDS: GENERAL
131 乳與奶油 MILK AND CREAM
133 乳酪與相關(guan)乳酪產品 CHEESES AND RELATED CHEESE PRODUCTS
135 冷(leng)凍(dong)點心 FROZEN DESSERTS
136 烘焙產品 BAKERY PRODUCTS
137 谷物粉與相(xiang)關產品 CEREAL FLOURS AND RELATED PRODUCTS
139 通心(xin)粉(fen)與面條(tiao)產品(pin) MACARONI ;AND NOODLE PRODUCTS
145 罐裝水果 CANNED FRUITS
146 罐裝(zhuang)水果汁 CANNED FRUIT JUICES
150 水果黃(huang)油、果凍、防腐劑以及相(xiang)關產品 FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS
152 水果餡餅(bing) FRUIT PIES
155 罐(guan)裝蔬菜(cai) CANNED VEGETABLES
156 蔬菜汁(zhi) VEGETABLE JUICES
158 冷凍蔬菜(cai) FROZEN VEGETABLES
160 蛋與(yu)蛋制品 EGGS AND EGG PRODUCTS
161 魚與有殼的(de)水生動(dong)物 FISH AND SHELLFISH
163 可可制(zhi)品(pin) CACAO PRODUCTS
164 樹堅果(guo)與花生制品(pin) TREE NUT AND PEANUT PRODUCTS
165 飲(yin)料 BEVERAGES
166 人造黃油(you) MARGARINE
168 增甜劑與餐桌糖漿 SWEETENERS AND TABLE SIRUPS
169 食品敷(fu)料與調(diao)味料 FOOD DRESSINGS AND FLAVORINGS
170 食品(pin)添加劑 FOOD ADDITIVES
171 食(shi)品(pin)添(tian)加劑申請 FOOD ADDITIVE PETITIONS
172 允許直接(jie)加入用于(yu)人類消(xiao)費食品的食品添加劑(ji) FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR HUMAN CONSUMPTION
173 在用于人類消(xiao)費的(de)食品中允許的(de)次直(zhi)接的(de)食品添加劑 SECONDARY DIRECT FOOD ADDITIVES PERMITTED IN FOOD FOR HUMAN CONSUMPTION
174 間接食品添加劑(ji)：總則(ze) INDIRECT FOOD ADDITIVES: GENERAL
175 間(jian)接(jie)食品添加(jia)劑：膠粘劑與涂層(ceng)的組(zu)分 INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS
176 間接(jie)食品添加劑：紙與紙板組分(fen) INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS
177 間接(jie)食品添加劑：聚合體 INDIRECT FOOD ADDITIVES: POLYMERS
178 間接食(shi)品添加劑：輔劑、生產助劑和消毒劑 INDIRECT FOOD ADDITIVES: ADJUVANTS, PRODUCTION AIDS, AND SANITIZERS
179 在食(shi)品生產、加工和處理中的輻照 IRRADIATION IN THE PRODUCTION, PROCESSING AND HANDLING OF FOOD
180 在額外試驗期間臨(lin)時在食品(pin)或(huo)者在與食品(pin)接(jie)觸中(zhong)被允(yun)許的(de)食品(pin)添加劑 FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONAL STUDY
181 先前(qian)核準的食品配料 PRIOR-SANCTIONED FOOD INGREDIENTS
182 一般(ban)認為(wei)安全的物質 SUBSTANCES GENERALLY RECOGNIZED AS SAFE
184 被確認為(wei)一(yi)般認為(wei)安全的(de)直接食(shi)品物質(zhi) DIRECT FOOD ;SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
186 被確認(ren)為(wei)一般認(ren)為(wei)安全的間(jian)接食品物質 INDIRECT FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE
189 禁止(zhi)用于人類(lei)食品的(de)物質 SUBSTANCES PROHIBITED FROM USE IN HUMAN FOOD
190 膳(shan)食補(bu)充劑 DIETARY SUPPLEMENTS
191-199 [預留的] [Reserved]
第C分章―藥品：總則（SUBCHAPTER C―DRUGS: GENERAL）
200 總(zong)則 GENERAL
201 標識 LABELING
202 處方藥廣(guang)告 PRESCRIPTION DRUG ADVERTISING
203 處方藥(yao)銷售 PRESCRIPTION DRUG MARKETING
205 對批發處方藥銷(xiao)售商頒發州執(zhi)照(zhao)的指南 GUIDELINES FOR STATE LICENSING OF WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS
206 人用固體口服劑(ji)型藥品的印碼 IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE
207 藥品生產(chan)者(zhe)的(de)登記與商業銷售的(de)藥品的(de)列表 REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL DISTRIBUTION
208 處方(fang)藥(yao)的藥(yao)物治療指導 MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS
210 制造(zao)、加工、包裝或者保存藥(yao)品的現行良好制造(zao)規(gui)范；總則 CURRENT GOOD ;MANUFACTURING PRACTICE IN MANUFACTURING, PROCESSING, PACKING, OR HOLDING OF DRUGS; GENERAL
211 對完(wan)成的藥品的現行良(liang)好制造(zao)規(gui)范 CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS ;
216 藥房配藥 PHARMACY COMPOUNDING
225 對含藥飼料的現行(xing)良好制造規范 CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS
226 對A型含(han)藥(yao)物品(pin)的現行良好制造規范 CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES
250 對特殊人用藥品的特殊要求(qiu) SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN DRUGS
290 管(guan)制的藥品 CONTROLLED DRUGS
299 藥(yao)品(pin)；正(zheng)式名稱(cheng)與已確定的名稱(cheng) DRUGS; OFFICIAL NAMES AND ESTABLISHED NAMES
第D分章(zhang)―人用藥品（SUBCHAPTER D―DRUGS FOR HUMAN USE）
300 總則 GENERAL
310 新藥 NEW DRUGS
312 試(shi)驗用新藥(yao)申請 INVESTIGATIONAL NEW DRUG APPLICATION ;
314 為(wei)FDA批(pi)準上市新(xin)藥(yao)的申(shen)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(xing)要求 BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS
328 含有酒精的(de)(de)預(yu)期用于口(kou)部攝(she)入(ru)的(de)(de)非處方藥品 OVER-THE-COUNTER DRUG PRODUCTS INTENDED FOR ORAL INGESTION THAT CONTAIN ALCOHOL
330 一(yi)般認為安全與有效以及不(bu)錯誤標識(shi)的(de)非(fei)處方人用(yong)藥品 OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED
331 用于非(fei)處方的人類(lei)使(shi)用的抗(kang)酸產品(pin) ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE
332 用(yong)(yong)于非(fei)處方(fang)的人類使(shi)用(yong)(yong)的抗胃腸氣脹(zhang)產品 ANTIFLATULENT PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ;
333 用(yong)于(yu)非處方的人(ren)類(lei)使用(yong)的局部抗(kang)菌(jun)藥品 TOPICAL ANTIMICROBIAL ;DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
335 用于非處方的人類使用的止瀉藥品 ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE ;
336 用于(yu)非處方的人類使用的止吐(tu)藥品 ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
338 用于非處(chu)方(fang)的人類使用的幫助夜間(jian)睡眠的藥品 NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
340 用于非處(chu)方(fang)的(de)人(ren)類使(shi)用的(de)興奮藥品 STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
341 用于非處方的人類使用的感冒、咳嗽、過敏(min)癥(zheng)藥、支(zhi)氣管擴張以及平喘藥品 COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
343 用(yong)于非(fei)處方的人類使(shi)用(yong)的內服的止痛、退熱以及抗風濕(shi)藥品 INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
344 用(yong)于非處方的(de)人類使用(yong)的(de)局(ju)部的(de)耳(er)部藥品 TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
346 用(yong)于非處方的人類使(shi)用(yong)的肛腸(chang)藥品(pin) ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
347 用于非(fei)處(chu)方的人類使用的皮(pi)膚保護藥品(pin) SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
348 用于非處(chu)方(fang)的(de)人類使用的(de)外(wai)部的(de)止痛(tong)藥品 EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
349 用(yong)于非處方的人類(lei)使用(yong)的眼科藥(yao)品 OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
350 用(yong)于非處方(fang)的(de)人(ren)類使用(yong)的(de)止汗藥品 ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
352 用(yong)于非(fei)處方(fang)的人(ren)類使用(yong)的遮光藥品 SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]
355 用(yong)(yong)于非(fei)處方的(de)人(ren)類使用(yong)(yong)的(de)防齲(qu)藥品 ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
357 用(yong)于非處方(fang)的(de)人類使(shi)用(yong)的(de)其他內(nei)服藥品(pin) MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
358 用于非處(chu)方(fang)的人(ren)類使用的其他外用藥品 MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
361 一(yi)般認(ren)為安全與有效以及不錯誤(wu)標識的(de)處(chu)方(fang)人用(yong)藥品(pin)：用(yong)于研究的(de)藥品(pin) PRESCRIPTION DRUGS FOR HUMAN USE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH
369 在用(yong)于非處方銷售的藥(yao)品與(yu)器械上關于警告的解(jie)釋性聲明 INTERPRETATIVE STATEMENTS RE WARNINGS ON ;DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE
370-499 [預留的] [Reserved]
第E分章―動物藥品、飲料和相(xiang)關(guan)產品（SUBCHAPTER E―ANIMAL DRUGS, ;FEEDS, AND RELATED PRODUCTS）
500 總則 GENERAL
501 動(dong)物食品標識 ANIMAL FOOD LABELING
502 非(fei)標準化(hua)的(de)動物食品的(de)普(pu)通(tong)(tong)的(de)或通(tong)(tong)常的(de)名稱 COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS
509 在動(dong)物食品與食品-包裝材料(liao)中(zhong)的(de)不可避免的(de)污染(ran)物(wu) UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL
510 新動物藥 NEW ANIMAL DRUGS
511 作為(wei)試驗用途的新動(dong)物藥 NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE
514 新(xin)動(dong)物藥(yao)申請(qing) NEW ANIMAL DRUG APPLICATIONS
515 含藥飼料廠執照 MEDICATED FEED MILL LICENSE
520 口服劑(ji)型的新動物藥 ORAL DOSAGE FORM ;NEW ANIMAL DRUGS
522 植入(ru)或者注射劑型的新動物(wu)藥 IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS
524 眼科(ke)和局部(bu)劑型的新(xin)動(dong)物(wu)藥 OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS
526 乳房內的劑型 INTRAMAMMARY DOSAGE FORMS ;
529 某些(xie)其他劑型的新動(dong)物藥 CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS
530 在(zai)動物中(zhong)的特別標(biao)簽藥(yao)品使用 EXTRALABEL DRUG USE IN ANIMALS
556 在食品中新動物(wu)藥殘留(liu)的(de)容許量 TOLERANCES FOR RESIDUES OF ;NEW ANIMAL DRUGS IN FOOD
558 用于動物(wu)飼料(liao)的新(xin)動物(wu)藥 NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS
564 [預(yu)留的] [Reserved]
570 食品添加劑(ji) FOOD ADDITIVES
571 食品添加劑申請(qing) FOOD ADDITIVE PETITIONS
573 在動物飼料與(yu)飲用水(shui)中允許的食品(pin)添加劑 FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS
579 在動物(wu)飼料和(he)寵物(wu)食(shi)品的(de)生產(chan)、加工和(he)處理(li)中的(de)輻(fu)照 IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD
582 一般認為(wei)安全的物質(zhi) SUBSTANCES GENERALLY RECOGNIZED AS SAFE
584 在(zai)動(dong)物飼料與飲用水中被確認為一般認為安全(quan)的食(shi)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(de)物質 SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED
590-599 [預留的] [Reserved]
第F分(fen)章―生物制品(pin)（SUBCHAPTER F―BIOLOGICS）
600 生物(wu)制品：總則(ze) BIOLOGICAL PRODUCTS: GENERAL
601 頒(ban)發執照 LICENSING
606 對血液與血液組分的現行(xing)良(liang)好制造規(gui)范 CURRENT GOOD ;MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS
607 對人類(lei)血(xue)液與血(xue)液制品(pin)的(de)(de)制造(zao)者(zhe)的(de)(de)機構登(deng)記與產品(pin)列表(biao) 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 對血(xue)(xue)液(ye)、血(xue)(xue)液(ye)組分和血(xue)(xue)液(ye)衍生物的一般(ban)要求(qiu) GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES
640 對(dui)人(ren)類血(xue)液和血(xue)液制品(pin)的(de)附加(jia)標準 ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS
660 對(dui)用于實驗室檢測的(de)診斷物質的(de)附加標(biao)準(zhun) ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS
680 對其他產品(pin)的附加(jia)標(biao)準 ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS
第G分章―化妝(zhuang)品（SUBCHAPTER G―COSMETICS）
700 總則 GENERAL
701 化妝品(pin)標識 COSMETIC LABELING
710 化妝品機構的自愿登記 VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS
720 化妝品配料構成聲明的自愿存檔 VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS
740 化妝品警告(gao)聲明 COSMETIC PRODUCT WARNING STATEMENTS
741-799 [預(yu)留的] [Reserved]
第H分章―醫(yi)療器械（SUBCHAPTER H―MEDICAL DEVICES）
800 總則 GENERAL
801 標識 LABELING
803 醫療器(qi)械報(bao)告(gao) MEDICAL DEVICE REPORTING
806 醫療器械；改正與移動的報告 MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
807 對器械的制造(zao)者(zhe)(zhe)與首次(ci)進口者(zhe)(zhe)的機(ji)構登記與器械列表 ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
808 對州和地方(fang)醫療器械要求的聯(lian)邦優先權的豁免 EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS
809 人用體外診斷產品 IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE
810 醫療(liao)器械召回權 MEDICAL DEVICE RECALL AUTHORITY
812 試(shi)驗用器械豁免 INVESTIGATIONAL DEVICE EXEMPTIONS ;
813 [預留的] [Reserved]
814 醫療器械(xie)的上市前批(pi)準(zhun) PREMARKET APPROVAL OF MEDICAL DEVICES
820 質量體(ti)(ti)系(xi)規章 QUALITY SYSTEM REGULATION
821 醫(yi)療(liao)器械跟蹤要(yao)求 MEDICAL DEVICE TRACKING REQUIREMENTS
822 上市后監視 POSTMARKET SURVEILLANCE
860 醫療(liao)器械分類程(cheng)序 MEDICAL DEVICE CLASSIFICATION PROCEDURES
861 性能標(biao)準制(zhi)定程序 PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT
862 臨(lin)(lin)床化學(xue)與臨(lin)(lin)床毒(du)理學(xue)器械 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
864 血液(ye)學與病理學器械 HEMATOLOGY AND PATHOLOGY DEVICES
866 免疫學(xue)與微(wei)生(sheng)物學(xue)器械 IMMUNOLOGY AND MICROBIOLOGY DEVICES
868 麻醉學器械 ANESTHESIOLOGY DEVICES
870 心(xin)血管器械 CARDIOVASCULAR DEVICES
872 牙(ya)科器(qi)械 DENTAL DEVICES
874 耳、鼻和(he)咽器(qi)械 EAR, NOSE, AND THROAT DEVICES
876 胃(wei)腸病(bing)學-泌(mi)尿學器械 GASTROENTEROLOGY-UROLOGY DEVICES
878 普通與整形(xing)外科(ke)器械 GENERAL AND PLASTIC SURGERY DEVICES
880 普通醫院(yuan)與(yu)個人(ren)使用器械(xie) GENERAL HOSPITAL AND PERSONAL USE DEVICES
882 神經學器械(xie) NEUROLOGICAL DEVICES
884 產科與婦科學(xue)器(qi)械(xie) OBSTETRICAL AND GYNECOLOGICAL DEVICES
886 眼科器械 OPHTHALMIC DEVICES
888 矯形外科器械 ORTHOPEDIC DEVICES
890 內(nei)科學器械 PHYSICAL MEDICINE DEVICES
892 放射學器(qi)械 RADIOLOGY DEVICES
895 禁止的(de)器(qi)械(xie) BANNED DEVICES
898 電極鉛(qian)線(xian)與患者電纜(lan)的(de)性能(neng)標(biao)準(zhun) PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES
第I分章(zhang)―乳房(fang)造影質量標準法(fa)（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDARDS ACT）
900 乳(ru)房(fang)造影法 MAMMOGRAPHY
第J分(fen)章―放射(she)學的健(jian)康（SUBCHAPTER J―RADIOLOGICAL HEALTH）
1000 總(zong)則 GENERAL
1002 記錄與報告 RECORDS AND REPORTS
1003 缺(que)陷與未能守(shou)法的(de)通報 NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY
1004 電(dian)子產品的回購、修理(li)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 電子產品的性(xing)能標準(zhun)：總則 PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL
1020 電離輻射發生產品的性(xing)能標準(zhun) PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS
1030 微波與射電頻率發生產(chan)品(pin)的性能標準 PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS
1040 發光產品的性能標準(zhun) PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
1050 聲波(bo)、次(ci)聲波(bo)和超聲波(bo)發(fa)生產品的性能標準 PERFORMANCE STANDARDS ;FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS
第K分(fen)章―[預留的(de)]（SUBCHAPTER K―[RESERVED]）
第L分章―根據由食品與藥品管理局行政執行的(de)某些其(qi)他(ta)法(fa)的(de)規章（SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION）
1210 根據(ju)《聯邦進口乳法》的(de)規章 REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT
1230 根據(ju)《聯邦(bang)腐蝕性毒物法》的(de)規章(zhang) REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT
1240 傳染病的控制(zhi) CONTROL OF COMMUNICABLE DISEASES
1250 州際運輸衛(wei)生 INTERSTATE CONVEYANCE SANITATION
1251-1269 [預留的] [Reserved]
1270 預期用于移植(zhi)的人(ren)體(ti)組織 HUMAN TISSUE INTENDED FOR TRANSPLANTATION
1271 人體細胞(bao)、組織(zhi)以及細胞(bao)的和基于組織(zhi)的產品 HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS
1272-1299 [預留的] [Reserved]
第Ⅱ章―司法部毒品強制執行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）
1300 定(ding)義 DEFINITIONS
1301 管(guan)制物質的(de)制造者(zhe)、分銷(xiao)者(zhe)和調劑(ji)者(zhe)的(de)登記(ji) REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES
1302 對(dui)管制物(wu)質的標識與包裝要(yao)求 LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES
1303 定(ding)額 QUOTAS
1304 登(deng)記(ji)者的記(ji)錄與報告(gao) RECORDS AND REPORTS OF REGISTRANTS
1305 令(ling)的格式 ORDER FORMS
1306 處方 PRESCRIPTIONS
1307 雜項 MISCELLANEOUS
1308 管制物(wu)質的表 SCHEDULES OF CONTROLLED SUBSTANCES
1309 表I化學品(pin)的制造者(zhe)、分(fen)銷者(zhe)、進口者(zhe)和出口者(zhe)的登記 REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS
1310 列入表的化學(xue)品和某些機器(qi)的記錄與報告(gao) RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES
1311 [預留(liu)的] [Reserved]
1312 管制物質的進口與(yu)出口 IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES
1313 前體(ti)與必要(yao)化學品的進口與出口 IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS
1314-1315 [預留的] [Reserved]
1316 行(xing)政職能、規(gui)范和程序 ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES
第Ⅲ章―毒品控(kong)制政策(ce)辦公室（CHAPTER Ⅲ―Office of National Drug Control Policy）
1400 [預留(liu)的] [Reserved]
1401 信(xin)息的公眾(zhong)可及性 PUBLIC AVAILABILITY OF INFORMATION
1402 強(qiang)制性解密審查(cha) MANDATORY DECLASSIFICATION REVIEW ;
1403 對給予州和地方(fang)政府(fu)資金(jin)和合作協議(yi)的統一行政要求(qiu) UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS
1404 政府范圍的排除與暫停（非獲(huo)得） GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)
1405 對無毒(du)品(pin)工作場所的政(zheng)府范圍的要求(qiu)（財政(zheng)援助） GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)&nbs
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