美国FDA《联邦规章典集》(CFR)第21篇目录(中英文)

TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICES1. General enforcement regulations2. General administrative rulings3. Product jurisdiction5. Organization7. Enforcement policy10. Administrative practices and procedures11. Format evidentiary public hearing12. Formal evidentiary a public hearing13. Public hearing before a public board of inquiry14. Public hearing before a public advisory committee15. Public hearing before the commissioner16. Regulatory hearing before the food and drug administration17. Civil money penalties hearings19. Standards of conduct and conflicts of interest20. Public information21. Protection of privacy25. Environmental impact considerations26. Mutual recognition of pharmaceutical good manufacturing prac50. Protection of human subjects54. Financial disclosure by clinical investigators56. Institutional review boards58. Good laboratory practice for nonclinical laboratory studies60. Patent term restoration70. Color additives71. Color additive petitions73. Listing of color additives exempt from certification74. Listing of color additives subject to certification80. Color additive certification81. General specifications and general restrictions for provision82. Listing of certified provisionally listed colors and specifications83-98 Reserved99 Dissemination of information on unapproved/new uses for mark100 General101 Food labeling102 Common or usual name for nonstandardized foods104 Nutritional quality guidelines for foods105 Foods for special dietary use106 Infant formula quality control procedures107 Infant formula108 Emergency permit control109 Unavoidable contaminants in food for human consumption and110 Current good manufacturing practice in manufacturing, packing 111 Current good manufacturing practice in manufacturing, package 113 Thermally processed low-acid foods packaged in hermetically114 Acidified foods115 Shell eggs118 Production, storage, and transportation of shell eggs119 Dietary supplements that present a significant or unreasonable120 Hazard analysis and critical control point(haccp) systems123 Fish and fishery products129 Processing and bottling of bottled drinking water130 Food standards: general131 Milk and cream133 Cheeses and related cheese products135 Frozen desserts136 Bakery products137 Cereal flours and related products139 Macaroni and noodle products145 Canned fruits146 Canned fruit juices150 Fruit butters, jellies, preserves, and related products152 Fruit pies155 Canned vegetables156 Vegetable juices158 Frozen vegetables160 Eggs and egg products161 Fish and shellfish163 Cacao products164 Tree nut and peanut products165 Beverages166 Margarine168 Sweeteners and table syrups169 Food dressings and flavorings170 Food additives171 Food additives petitions172 Food additives permitted for direct addition to food for human173 Secondary direct food additives permitted in food for human174 Indirect food additives: general175 Indirect food additives: adhesives and components of coating 176 Indirect food additives: paper and paperboard components177 Indirect food additives: polymers178 Indirect food additives: adjuvants, production aids, and179 Irradiation in the production, processing and handing of180 Food additives permitted in food or in contact with food on181 Prior-sanctioned food ingredients182 Substances generally recognized as safe184 Direct food substance affirmed as generally recognized as186 Indirect food substance affirmed as generally recognized as 189 Substances prohibited from use in human food190 Dietary supplements191-199 reserved200 General201 Labeling202 Prescription drug advertising203 Prescription drug marketing205 Guidelines for stat licensing of wholesale prescription drug206 Imprinting of solid oral dosage form drug products for human 207 Registration of producers of drugs and listing of drugs in208 Medication guides for prescription drug products209 Requirement for authorized dispensers and pharmacies to dist.. 210 Current good manufacturing practice in manufacturing, process 211 Current good manufacturing practice in finished pharmaceuti216 Pharmacy compounding225 Current good manufacturing practice for medicated feeds226 Current good manufacturing practice for type a medicated art… 250 Special requirements for specific human drugs290 Controlled drugs299 Drugs; official names and established names300 General310 New drugs312 Investigational new drug application314 Applications for FDA approval to market a new drug315 Diagnostic radiopharmaceuticals316 Orphan drugs320 Bioavailability and bioequivalence requirements328 Over-the-counter drug products intended for oral ingestion330 Over-the-counter(otc) human drugs which are generally recognize331 Antacid products for over-the-counter(otc) human use332 Antiflatulent products for over-the-counter human use333 Topical antimicrobial drug products for Over-the-counter human335 Antidiarrheal drug products for over-the counter human use336 Antiemetic drug products for over-the-counter human use338 Nighttime sleep-aid drug products for over-the-counter human340 Stimulant drug products for over-the-counter human use341 Cold, cough, allergy, bronchodilator, and antiasthmatic drug343 Internal analgesic, antipyretic, and antirheumatic drug product344 Topical otic drug products for over-the-counter human use346 Anorectal drug products for over-the-counter human use347 Skin protectant drug products for over-the-counter use348 External analgesic drug products for over-the-counter human349 Ophthalmic drug products for over-the-counter human use350 Antiperspirant drug products for over-the-counter human use352 Sunscreen drug products for over-the-counter human use [stay355 Anticaries drug products for over-the-counter human use357 Miscellaneous internal drug products for over-the-counter human use 358 Miscellaneous external drug products for over-the-counter human use 361 Prescription drugs for human use generally recognized as safe369 Interpretative statements re warnings on drugs and devices370-499 reserved500 General501 Animal food labeling502 Common or usual names for nonstandardized animal foods509 Unavoidable contaminants in animal food and food-packaging510 New animal drugs511 New animal drugs for investigational use514 New animal drugs applications515 Medicated feed mill license516 New animal drugs for minor use and minor species520 Oral dosage form new animal drugs522 Implantation or injectable dosage form new animal drugs524 Ophthalmic and topical dosage form new animal drugs526 Intramammary dosage forms528 New animal drugs in genetically engineered animals529 Certain other dosage form new animal drugs530 Extralabel drug use in animals556 New animal drugs for use in animal feeds564 reserved570 Food additives571 Food additive petitions573 Food additives permitted in feed and drinking water of animal 579 Irradiation in the production, processing, and handing of582 Substances generally recognized as safe584 Food substances generally recognized as safe589 Substances prohibited from use in animal food or feed590-599 reserved600 Biological products: general601 Licensing606 Current good manufacturing practice for blood and blood comp607 Establishment registration and product listing for manufacturers610 General biological products standards630 General requirements for blood, blood components, and blood640 Additional standards for human blood and blood products660 Additional standards for diagnostic substances for laborator680 Additional standards for miscellaneous products700 General701 Cosmetic labeling710 Voluntary registration of cosmetic product establishments720 Voluntary filing of cosmetic product ingredient composition740 Cosmetic product warning statements741-799 reserved800 General801 Labeling803 Medical device reporting806 Medical devices; reports of corrections and removals807 Establishment registration and device listing for manufacturer808 Exemptions from federal preemption of state and local medical809 In vitro diagnostic products for human use810 Medical device recall authority812 Investigational device exemptions813 reserved814 Premarket approval of medical devices820 Quality system regulation821 Medical device tracking requirements822 Postmarket surveillance860 Medical device classification procedures861 Procedures for performance standards development862 Clinical chemistry and clinical toxicology devices864 Hematology and pathology devices866 Immunology and microbiology devices868 Anesthesiology devices870 Cardiovascular devices872 Dental devices874 Ear, nose, and throat devices876 Gastroenterology-urology devices878 General and plastic surgery devices880 General hospital and personal use devices882 Neurological devices884 Obstetrical and gynecological devices886 Ophthalmic devices888 Orthopedic devices890 Physical medicine devices892 Radiology devices895 Banned devices898 Performance standard for electrode lead wires and patient900 Mammography1000 General1002 Records and reports1003 Notification of defects or failure to comply1004 Repurchase, repairs, or replacement of electronic products 1005 Importation of electronic products1010 Performance standards for electronic products: general1020 Performance standards for ionizing radiation emitting product 1030 Performance standards for microwave and radio frequency emit 1040 Performance standards for light-emitting products1050 Performance standards for sonic, infrasonic, and ultrasonic 1140 Cigarettes and smokeless tobacco1210 Regulations under the federal import milk act1230 Regulations under the federal caustic poison act1240 Control of communicable diseases1250 Interstate conveyance sanitation1251-1269 reserved1270 Human tissue intended for transplantation1271 Human cells, tissues, and cellular and tissue-based products 1272-1299 reserved1300 Definitions1301 Registration of manufacturers, distributors, and dispensers 1302 Labeling and packaging requirements for controlled substance 1303 Quotas1304 Records and reports of registrants1305 Orders for schedule I an ii controlled substances1306 Prescriptions1307 Miscellaneous1308 Schedules of controlled substances1309 Registration of manufacturers, distributors, importers and 1310 Records and reports of listed chemicals and certain machines 1311 Requirements for electronic orders and prescriptions1312 Importation and exportation of controlled substances1313 Importation and exportation of list I and ii chemicals1314 Retail sale of scheduled listed chemical products1315 Administrative functions, practices, and procedures1321 Dea mailing addresses1400 reserved1401 Public availability of information1402 Mandatory declassification review1403 Uniform administrative requirements for grants and cooperation 1404 Governmentwide debarment and suspension(nonprocurement)1405 Governmentwide requirements for drug-free workplace (financial) 1406-1499 reserved.。

FDA 21 CFR QSR820 中英文对照版本1 / 4621 CFR § 820Quality System Regulation质量体系手册Subpart A —General ProvisionsA 部分——总则820.1 Scope.820.1范围820.3 Definitions.定义820.5 Quality system.质量体系Subpart B —Quality SystemRequirementsB 部分——质量体系要求820.20 Management responsibility.管理者职责820.22 Quality audit. 质量审核 820.25 Personnel. 职员 Subpart C —Design Controls C 部分——设计控制 820.30 Design controls. 设计控制 Subpart D —Document Controls D 部分——文件控制 820.40 Document controls. 文件控制 Subpart E —Purchasing Controls E 部分——采购控制 820.50 Purchasing controls.采购控制Subpart F—Identification and TraceabilityF部分——标识和可追溯性820.60 Identification.标识820.65 Traceability.可追溯性Subpart G—Production and Process ControlsG部分——生产和过程控制820.70 Production and process controls.产品和过程控制820.72Inspection,measuring, and test equipment.检查、测量，测试仪器820.75 Process validation.过程确认Subpart H—Acceptance ActivitiesH部分—接收活动820.80 Receiving, in-process, and finished device acceptance.接收设备准则，过程设备准则，最终设备准则820.86 Acceptance status.接收状态Subpart I—Nonconforming Product I部分——不合格产品820.90 Nonconforming product.不合格产品Subpart J—Corrective and Preventive ActionJ部分——纠正预防措施820.100 Corrective and preventive action.纠正预防措施Subpart K—Labeling and Packaging ControlK部分——标签与包装控制820.120 Device labeling.产品标识820.130 Device packaging.产品包装Subpart L—Handling, Storage, Distribution, and InstallationL部分——操作、存储、分配以及安装820.140 Handling.操作820.150 Storage.存储820.160 Distribution.分配820.170 Installation.安装2 / 46Subpart M—RecordsM部分——记录820.180 General requirements.总要求820.181 Device master record.产品控制记录820.184 Device history record.产品历史记录820.186 Quality system record.质量体系记录820.198 Complaint files.客户抱怨文件Subpart N—Servicing820.200 Servicing.Subpart O—Statistical Techniques820.250 Statistical techniques.Authority: Secs. 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383).Subpart A—General Provisions3§ 820.1 Scope.3Subpart A—General Provisions§ 820.1 Scope.820.1范围(a) Applicability.适用性(1) Current good manufacturing practice (CGMP) requirementsare set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and3 / 46effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject to the requirements in this part, and not in others, thatcomponents or parts of finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance. Manufacturers of human blood and blood components are not subject to this part, but are subject to part 606 of this chapter.在本质量体系法规（QSR）中阐述了CGMP的要求。

美国联邦法规法典第21册第I章健康与人类服务部食品与药品管理局第H小章医疗器械第820部分质量体系法规2014年4月子部分A---总则§820.1范围(a)适用性(1)质量体系法规规定了对现行良好制造法规(CGMP)的要求。

本部分的要求，决定了预期为人类使用的所有成品器械的设计、制造、包装、标记、储存、安装和服务中使用的方法、设施和控制。

本部分的要求意在确保成品器械安全、有效，并且符合联邦食品、药品和化妆品法令。

本部分确定的基本要求适用于成品医疗器械的制造商。

如果制造商仅从事受本法规的要求制约的某些操作，其它操作不受制约，则制造商只须符合适用其操作的要求。

对于I类器械，设计控制只适用于在§820.30(a)(2)中列出的器械。

本法规不适用于为成品器械提供组件或零件的制造商，但鼓励他们将本法规中的适当规定作为指导。

人类血液及血液成分的制造商不受法规本部分的约束，但受本章606部分的约束。

如同本章1271.3(d)所定义的那样，人类细胞、组织、细胞组成的和基于人体组织的产品（HCT /PS)，属于医疗器械产品（遵循上市前评审或通知，或豁免通知，基于一种据法案之器械规定所提交的申请或基于一种符合公卫生服务法案第351节的生物产品许可申请），这些产品遵循本法规且也遵循本章的第1271部分C子部分阐明的捐赠者一合格性程序以及第1271部分D子部分之适用的现行优良组织规范程序。

若发生第1271部分的适用规章与本章的其他部分相矛盾的情况，专门适用于所讨论器械的规章将取代较为一般的规章。

(2)联邦法规法典本部分的规定应适用于由本部分定义的、预期为人类使用的任何成品器械，只要这些器械在在美国任何州或领土、哥伦比亚特区或波多黎哥共同体制造、向其进口或提供向其进口。

(3)本法规多次使用了词组“适当时”。

当一项要求冠以“适当时”，除非制造商能以文件形式提出其它合理理由，它即被认为是“适当的”。

一项要求如果不予实施，即有理由认为预期产品不满足其规定的要求，或者制造商不能采取任何必要的纠正措施，则此种要求是“适当的”。

New Search Help 6 | More About 21CFR 7[Code of Federal Regulations][Title 21, Volume 2][Revised as of April 1, 2013][CITE: 21CFR110.10]TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER B--FOOD FOR HUMAN CONSUMPTIONPART 110 -- CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKING,OR HOLDING HUMAN FOODSubpart A--General ProvisionsSec. 110.10 Personnel.The plant management shall take all reasonable measures and precautions toensure the following:(a)Disease control. Any person who, by medical examination or supervisoryobservation, is shown to have, or appears to have, an illness, open lesion,including boils, sores, or infected wounds, or any other abnormal source ofmicrobial contamination by which there is a reasonable possibility of food,food-contact surfaces, or food-packaging materials becoming contaminated,shall be excluded from any operations which may be expected to result insuch contamination until the condition is corrected. Personnel shall beinstructed to report such health conditions to their supervisors.(b)Cleanliness. All persons working in direct contact with food, food-contact surfaces, and food-packaging materials shall conform to hygienicpractices while on duty to the extent necessary to protect againstcontamination of food. The methods for maintaining cleanliness include, butare not limited to:(1) Wearing outer garments suitable to the operation in a manner thatprotects against the contamination of food, food-contact surfaces, or food-packaging materials.(2) Maintaining adequate personal cleanliness.(3) Washing hands thoroughly (and sanitizing if necessary to protectagainst contamination with undesirable microorganisms) in an adequate hand-washing facility before starting work, after each absence from the workstation, and at any other time when the hands may have become soiled orcontaminated.(4) Removing all unsecured jewelry and other objects that might fall intofood, equipment, or containers, and removing hand jewelry that cannot beadequately sanitized during periods in which food is manipulated by hand.If such hand jewelry cannot be removed, it may be covered by material whichcan be maintained in an intact, clean, and sanitary condition and whicheffectively protects against the contamination by these objects of thefood, food-contact surfaces, or food-packaging materials.CFR - Code of Federal Regulations Title 21FDA Home 3 Medical Devices 4 Databases 5(5) Maintaining gloves, if they are used in food handling, in an intact,clean, and sanitary condition. The gloves should be of an impermeablematerial.(6) Wearing, where appropriate, in an effective manner, hair nets,headbands, caps, beard covers, or other effective hair restraints.(7) Storing clothing or other personal belongings in areas other than wherefood is exposed or where equipment or utensils are washed.(8) Confining the following to areas other than where food may be exposedor where equipment or utensils are washed: eating food, chewing gum,drinking beverages, or using tobacco.(9) Taking any other necessary precautions to protect against contaminationof food, food-contact surfaces, or food-packaging materials withmicroorganisms or foreign substances including, but not limited to,perspiration, hair, cosmetics, tobacco, chemicals, and medicines applied tothe skin.(c)Education and training. Personnel responsible for identifying sanitationfailures or food contamination should have a background of education orexperience, or a combination thereof, to provide a level of competencynecessary for production of clean and safe food. Food handlers andsupervisors should receive appropriate training in proper food handlingtechniques and food-protection principles and should be informed of thedanger of poor personal hygiene and insanitary practices.(d)Supervision. Responsibility for assuring compliance by all personnelwith all requirements of this part shall be clearly assigned to competentsupervisory personnel.[51 FR 22475, June 19, 1986, as amended at 54 FR 24892, June 12, 1989]Links on this page:1. /bookmark.php?u508=true&v=152&username=fdamain2. /bookmark.php3. /default.htm4. /MedicalDevices/default.htm5. /MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm6. /scripts/cdrh/cfdocs/search/default.cfm?FAQ=true7. /MedicalDevices/DeviceRegulationandGuidance/Databases/ucm135680.htmPage Last Updated: 04/01/2013Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website PoliciesU.S. Food and Drug Administration10903 New Hampshire AvenueSilver Spring, MD 20993Ph. 1-888-INFO-FDA (1-888-463-6332)Email FDAFor Government For PressCombination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing EducationInspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA ArchiveLinks on this page:1. /bookmark.php?u508=true&v=152&username=fdamain2. /bookmark.php3. /default.htm4. /MedicalDevices/default.htm5. /MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm6. /scripts/cdrh/cfdocs/search/default.cfm?FAQ=true7. /MedicalDevices/DeviceRegulationandGuidance/Databases/ucm135680.htm。

精品文档[Code of Federal Regulations] ] [联邦法规[Title 21, Volume 1] ]卷第21章第1[[Revised as of April 1, 2006] ] 日修改月01年[200604[CITE:21CFR 11]21CFR 11] [代号：TITLE 21--Food And Drugs章－食品与药品第21CHAPTER I--Food And Drug Administration节－食品和药品管理局第1Department of Health And Human Services 健康与人类服务部Subchapter A--General 亚节－一般规定PART 11 Electronic Records;Electronic电子记录；电子签名第11款SignaturesSubpart A--General ProvisionsA 一般规定分章Sec. 11.1 Scope.11.1适用范围the forth this part set in (a) 本条款的规则提供了标准，在此标准(a) The regulationsconsidersagency under which the criteria 将认为电子记录、电子签名、FDA之下and signatures, electronic records, electronic 和在电子记录上的手签名是可信赖的、electronicto handwritten signatures executed 可靠的并且通常等同于纸制记录和在纸records to be trustworthy, reliable, and generally上的手写签名。

handwrittenand to paper records equivalentsignatures executed on paper.(b) This part applies to records in electronic form 规则中阐明的本条款适用于在FDA(b) that are created, modified, maintained, archived, 在任何记录的要求下，以电子表格形式recordsany transmitted, under retrieved, or 建立、修改、维护、归档、检索或传送requirements set forth in agency regulations. 的记录。

801.1Medical devices;name and place of business of manufacturer,packer or distributor.医疗器械，制造商、包装商或分销商的经营名称和地址(a)The label of a device in package form shall specify conspicuously the name and placeof business of the manufacturer,packer,or distributor.器械包装的标标识上应醒目地标明制造商、包装商或分销商的经营名称和地址。

(b)(b)The requirement for declaration of the name of the manufacturer,packer,ordistributor shall be deemed to be satisfied,in the case of a corporation,only by theactual corporate name which may be preceded or followed by the name of theparticular division of the corporation.Abbreviations for"Company,""Incorporated,"etc.,may be used and"The"may be omitted.In the case of an individual,partnership,or association,the name under which the business is conducted shall be used.对于制造商、包装商或分销商的名称，要提供公司的真实名称，在公司名称的前后可列出该公司特定部门的名称。

Help7 | More About 21CFR 8
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三、质量体系要求
• 设备是否未能满足规范 • 设备是否用于治疗或诊断 • 以及相关的传闻的事故事件 e. 调查进行中，应保持记录，包括： • 设备名称 • 接到投诉的日期 • 设备身份和控制号码 • 投诉者姓名、地址、电话号码 • 投诉的类型和详细情况
• 调查处理单位到海外，记录也应是适当的，在美国容易理解的
从事验证和确认的人员应知道在其职能上可能遭遇的缺陷和错
误
三、质量体系要求
Sec. 820.40设计控制
•
•
• • • • • • •
建立程序
设计开发计划，包括职责、设计活动、活动界面、设计输入，该计划应及时更新
设计输入，包括寻找不完整的、模糊的、自相矛盾的机制，输入应文件化并得到评审 和批准，批准应包括签名、时间 设计输出，应评估输出文件的符合性，输出文件应包括接收标准、基本参数，输出应 得到评审和批准 审计评审/设计历史文件 设计验证 /设计历史文件 设计确认/设计验证文件包括识别方法、日期、执行人 设计转移，设计正确地转化成产品规范 设计变更
三、质量体系要求
Sec. 820.20 管理职责 a. 质量方针 b. 组织结构 c. 职责权限 d. 资源
e. 管理者代表
f. 管理评审 g. 质量计划
h. 质量体系程序
三、质量体系要求
Sec. 820.22 质量审核 Sec. 820.25 员工 • • 总则 培训（建立程序） 员工应知道不适当的行为将导致的设备缺陷
•
• •
执行和记录方法或程序的变更
确保质量问题或不合格的相关信息传递到相关部门 提交管理评审
b. 形成记录
三、质量体系要求
Sec. 820.120 产品标签
建立程序控制标签 a. 标签完整：标签应打印并在产品流转中确保标签清晰，粘贴牢固

美国FDA《联邦规章典集》（CFR）第21篇目录中文版发布时间：2010-5-11 13:44:12 发布方：奥咨达医疗器械咨询美国《联邦规章典集》（CFR）第21篇“食品与药品”总目概述：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（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”（Tit le 21―Food and Drugs）的概况卷（Volume）章（Chapter）部（Parts）规制机关（Regulatory Entity）1 Ⅰ1-99 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）2 100-1693 170-1994 200-2995 300-4996 500-5997 600-7998 800-12999 Ⅱ1300-1399 司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）Ⅲ1400-1499 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 ADMINIST RATION, 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 REGULATIONS2 一般行政规则与决定GENERAL ADMINISTRATIVE RULINGS AND DECISIONS3 产品管辖权PRODUCT JURISDICTION5 组织ORGANIZATION7 强制执行政策ENFORCEMENT POLICY10 行政规范与程序ADMINISTRATIVE PRACTICES AND PROCEDURES11 电子化记录；电子化签名ELECTRONIC RECORDS; ELECTRONIC SIGNATURES12 正式证据的公众听证FORMAL EVIDENTIARY PUBLIC HEARING13 在公众质询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY14 在公众咨询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE15 在FDA局长前的公众听证PUBLIC HEARING BEFORE THE COMMISSIONER16 在FDA前的规制性听证REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION17 行政罚款听证CIVIL MONEY PENALTIES HEARINGS19 行为标准与利益冲突STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST20 公共信息PUBLIC INFORMATION21 隐私保护PROTECTION OF PRIVACY25 环境影响考虑ENVIRONMENTAL IMPACT CONSIDERATIONS26 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 COMMUNITY50 人类受试者的保护PROTECTION OF HUMAN SUBJECTS54 临床试验者的财务公开FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS56 机构审查委员会INSTITUTIONAL REVIEW BOARDS58 对非临床实验室研究的良好实验室规范GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES60 专利期恢复PATENT TERM RESTORATION70 色素添加剂COLOR ADDITIVES71 色素添加剂申请COLOR ADDITIVE PETITIONS73 免除认证的色素添加剂的列表LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION74 适用认证的色素添加剂的列表LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION80 色素添加剂认证COLOR ADDITIVE CERTIFICATION81 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 COSMETICS82 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 SPECIFICATIONS83-98 [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GENERAL101 食品标识FOOD LABELING102 非标准化食品的普通的或者通常的名称COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS104 食品的营养质量指南NUTRITIONAL QUALITY GUIDELINES FOR FOODS105 特殊膳食用途的食品FOODS FOR SPECIAL DIETARY USE106 婴儿配方母乳替代食品质量控制程序INFANT FORMULA QUALITY CONTROL PROCEDURES107 婴儿配方母乳替代食品INFANT FORMULA108 紧急许可控制EMERGENCY PERMIT CONTROL109 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 MATERIAL110 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 FOOD113 装在密封容器中的热加工低酸食品THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS114 酸化食品ACIDIFIED FOODS115 带壳蛋SHELL EGGS119 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 RISK120 危害分析与关键控制点（HACCP）体系HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS123 鱼与渔业产品FISH AND FISHERY PRODUCTS129 饮用水加工与装瓶PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER130 食品标准：总则FOOD STANDARDS: GENERAL131 乳与奶油MILK AND CREAM133 乳酪与相关乳酪产品CHEESES AND RELATED CHEESE PRODUCTS135 冷冻点心FROZEN DESSERTS136 烘焙产品BAKERY PRODUCTS137 谷物粉与相关产品CEREAL FLOURS AND RELATED PRODUCTS139 通心粉与面条产品MACARONI AND NOODLE PRODUCTS145 罐装水果CANNED FRUITS146 罐装水果汁CANNED FRUIT JUICES150 水果黄油、果冻、防腐剂以及相关产品FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS152 水果馅饼FRUIT PIES155 罐装蔬菜CANNED VEGETABLES156 蔬菜汁VEGETABLE JUICES158 冷冻蔬菜FROZEN VEGETABLES160 蛋与蛋制品EGGS AND EGG PRODUCTS161 鱼与有壳的水生动物FISH AND SHELLFISH163 可可制品CACAO PRODUCTS164 树坚果与花生制品TREE NUT AND PEANUT PRODUCTS165 饮料BEVERAGES166 人造黄油MARGARINE168 增甜剂与餐桌糖浆SWEETENERS AND TABLE SIRUPS169 食品敷料与调味料FOOD DRESSINGS AND FLAVORINGS170 食品添加剂FOOD ADDITIVES171 食品添加剂申请FOOD ADDITIVE PETITIONS172 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 CONSUMPTION173 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 CONSUMPTION174 间接食品添加剂：总则INDIRECT FOOD ADDITIVES: GENERAL175 间接食品添加剂：胶粘剂与涂层的组分INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS176 间接食品添加剂：纸与纸板组分INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS177 间接食品添加剂：聚合体INDIRECT FOOD ADDITIVES: POLYMERS178 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 FOOD180 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 STUDY181 先前核准的食品配料PRIOR-SANCTIONED FOOD INGREDIENTS182 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE184 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 FOOD190 膳食补充剂DIETARY SUPPLEMENTS191-199 [预留的] [Reserved]第C分章―药品：总则（SUBCHAPTER C―DRUGS: GENERAL）200 总则GENERAL201 标识LABELING202 处方药广告PRESCRIPTION DRUG ADVERTISING203 处方药销售PRESCRIPTION DRUG MARKETING205 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 DISTRIBUTORS206 人用固体口服剂型药品的印码IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE207 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 DISTRIBUTION208 处方药的药物治疗指导MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS210 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; GENERAL211 对完成的药品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS216 药房配药PHARMACY COMPOUNDING225 对含药饲料的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS226 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 DRUGS290 管制的药品CONTROLLED DRUGS299 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GENERAL310 新药NEW DRUGS312 试验用新药申请INVESTIGATIONAL NEW DRUG APPLICATION314 为FDA批准上市新药的申请APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG315 诊断用放射性药品DIAGNOSTIC RADIOPHARMACEUTICALS316 罕见病药ORPHAN DRUGS320 生物利用度与生物等效性要求BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS328 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 ALCOHOL330 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 MISBRANDED331 用于非处方的人类使用的抗酸产品ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE332 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 USE333 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 USE335 用于非处方的人类使用的止泻药品ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE336 用于非处方的人类使用的止吐药品ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE338 用于非处方的人类使用的帮助夜间睡眠的药品NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE340 用于非处方的人类使用的兴奋药品STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE341 用于非处方的人类使用的感冒、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 USE343 用于非处方的人类使用的内服的止痛、退热以及抗风湿药品INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE344 用于非处方的人类使用的局部的耳部药品TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE346 用于非处方的人类使用的肛肠药品ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE347 用于非处方的人类使用的皮肤保护药品SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE348 用于非处方的人类使用的外部的止痛药品EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE349 用于非处方的人类使用的眼科药品OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE350 用于非处方的人类使用的止汗药品ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE352 用于非处方的人类使用的遮光药品SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]355 用于非处方的人类使用的防龋药品ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE357 用于非处方的人类使用的其他内服药品MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE358 用于非处方的人类使用的其他外用药品MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE361 一般认为安全与有效以及不错误标识的处方人用药品：用于研究的药品PRESCRIPTION DRUGS FOR HUMAN USE GENERALLYRECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH369 在用于非处方销售的药品与器械上关于警告的解释性声明INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE370-499 [预留的] [Reserved]第E分章―动物药品、饮料和相关产品（SUB CHAPTER E―ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS）500 总则GENERAL501 动物食品标识ANIMAL FOOD LABELING502 非标准化的动物食品的普通的或通常的名称COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS509 在动物食品与食品-包装材料中的不可避免的污染物UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL510 新动物药NEW ANIMAL DRUGS511 作为试验用途的新动物药NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE514 新动物药申请NEW ANIMAL DRUG APPLICATIONS515 含药饲料厂执照MEDICATED FEED MILL LICENSE520 口服剂型的新动物药ORAL DOSAGE FORM NEW ANIMAL DRUGS522 植入或者注射剂型的新动物药IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS524 眼科和局部剂型的新动物药OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS526 乳房内的剂型INTRAMAMMARY DOSAGE FORMS529 某些其他剂型的新动物药CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS530 在动物中的特别标签药品使用EXTRALABEL DRUG USE IN ANIMALS556 在食品中新动物药残留的容许量TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD558 用于动物饲料的新动物药NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS564 [预留的] [Reserved]570 食品添加剂FOOD ADDITIVES571 食品添加剂申请FOOD ADDITIVE PETITIONS573 在动物饲料与饮用水中允许的食品添加剂FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS579 在动物饲料和宠物食品的生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD582 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE584 在动物饲料与饮用水中被确认为一般认为安全的食品物质FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS589 禁止用于动物食品或者饲料的物质SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED590-599 [预留的] [Reserved]第F分章―生物制品（SUB CHAPTER F―BIOLOGICS）600 生物制品：总则BIOLOGICAL PRODUCTS: GENERAL601 颁发执照LICENSING606 对血液与血液组分的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS607 对人类血液与血液制品的制造者的机构登记与产品列表ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS610 普通生物制品标准GENERAL BIOLOGICAL PRODUCTS STANDARDS630 对血液、血液组分和血液衍生物的一般要求GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES640 对人类血液和血液制品的附加标准ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS660 对用于实验室检测的诊断物质的附加标准ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS680 对其他产品的附加标准ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS第G分章―化妆品（SUBCHAPTER G―COSMETICS）700 总则GENERAL701 化妆品标识COSMETIC LABELING710 化妆品机构的自愿登记VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS720 化妆品配料构成声明的自愿存档VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS740 化妆品警告声明COSMETIC PRODUCT WARNING STATEMENTS741-799 [预留的] [Reserved]第H分章―医疗器械（SUBCHAPTER H―MEDICAL DEVICES）800 总则GENERAL801 标识LABELING803 医疗器械报告MEDICAL DEVICE REPORTING806 医疗器械；改正与移动的报告MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS807 对器械的制造者与首次进口者的机构登记与器械列表ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES808 对州和地方医疗器械要求的联邦优先权的豁免EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS809 人用体外诊断产品IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE810 医疗器械召回权MEDICAL DEVICE RECALL AUTHORITY812 试验用器械豁免INVESTIGATIONAL DEVICE EXEMPTIONS813 [预留的] [Reserved]814 医疗器械的上市前批准PREMARKET APPROVAL OF MEDICAL DEVICES820 质量体系规章QUALITY SYSTEM REGULATION821 医疗器械跟踪要求MEDICAL DEVICE TRACKING REQUIREMENTS822 上市后监视POSTMARKET SURVEILLANCE860 医疗器械分类程序MEDICAL DEVICE CLASSIFICATION PROCEDURES861 性能标准制定程序PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT862 临床化学与临床毒理学器械CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES864 血液学与病理学器械HEMATOLOGY AND PATHOLOGY DEVICES866 免疫学与微生物学器械IMMUNOLOGY AND MICROBIOLOGY DEVICES868 麻醉学器械ANESTHESIOLOGY DEVICES870 心血管器械CARDIOVASCULAR DEVICES872 牙科器械DENTAL DEVICES874 耳、鼻和咽器械EAR, NOSE, AND THROAT DEVICES876 胃肠病学-泌尿学器械GASTROENTEROLOGY-UROLOGY DEVICES878 普通与整形外科器械GENERAL AND PLASTIC SURGERY DEVICES880 普通医院与个人使用器械GENERAL HOSPITAL AND PERSONAL USE DEVICES882 神经学器械NEUROLOGICAL DEVICES884 产科与妇科学器械OBSTETRICAL AND GYNECOLOGICAL DEVICES886 眼科器械OPHTHALMIC DEVICES888 矫形外科器械ORTHOPEDIC DEVICES890 内科学器械PHYSICAL MEDICINE DEVICES892 放射学器械RADIOLOGY DEVICES895 禁止的器械BANNED DEVICES898 电极铅线与患者电缆的性能标准PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES第I分章―乳房造影质量标准法（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDA RDS ACT）900 乳房造影法MAMMOGRAPHY第J分章―放射学的健康（SUBCHAPTER J―RADIOLOGICAL HEALTH）1000 总则GENERAL1002 记录与报告RECORDS AND REPORTS1003 缺陷与未能守法的通报NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY1004 电子产品的回购、修理或者置换REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS1005 电子产品的进口IMPORTATION OF ELECTRONIC PRODUCTS1010 电子产品的性能标准：总则PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL1020 电离辐射发生产品的性能标准PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS1030 微波与射电频率发生产品的性能标准PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS1040 发光产品的性能标准PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS1050 声波、次声波和超声波发生产品的性能标准PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS第K分章―[预留的]（SUBCHAPTER K―[RESERVED]）第L分章―根据由食品与药品管理局行政执行的某些其他法的规章（SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION）1210 根据《联邦进口乳法》的规章REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT1230 根据《联邦腐蚀性毒物法》的规章REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT1240 传染病的控制CONTROL OF COMMUNICABLE DISEASES1250 州际运输卫生INTERSTATE CONVEYANCE SANITATION1251-1269 [预留的] [Reserved]1270 预期用于移植的人体组织HUMAN TISSUE INTENDED FOR TRANSPLANTATION1271 人体细胞、组织以及细胞的和基于组织的产品HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS 1272-1299 [预留的] [Reserved]第Ⅱ章―司法部毒品强制执行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）1300 定义DEFINITIONS1301 管制物质的制造者、分销者和调剂者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES1302 对管制物质的标识与包装要求LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES1303 定额QUOTAS1304 登记者的记录与报告RECORDS AND REPORTS OF REGISTRANTS1305 令的格式ORDER FORMS1306 处方PRESCRIPTIONS1307 杂项MISCELLANEOUS1308 管制物质的表SCHEDULES OF CONTROLLED SUBSTANCES1309 表I化学品的制造者、分销者、进口者和出口者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS1310 列入表的化学品和某些机器的记录与报告RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES 1311 [预留的] [Reserved]1312 管制物质的进口与出口IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES1313 前体与必要化学品的进口与出口IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS1314-1315 [预留的] [Reserved]1316 行政职能、规范和程序ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES第Ⅲ章―毒品控制政策办公室（CHAPTER Ⅲ―Office of National Drug Control Policy）1400 [预留的] [Reserved]1401 信息的公众可及性PUBLIC AVAILABILITY OF INFORMATION1402 强制性解密审查MANDATORY DECLASSIFICATION REVIEW1403 对给予州和地方政府资金和合作协议的统一行政要求UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS1404 政府范围的排除与暂停（非获得）GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)1405 对无毒品工作场所的政府范围的要求（财政援助）GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)1406-1499 [预留的] [Reserved]。

美国FDA《联邦规章典集》（CFR）第21篇目录中文版发布时间：2010-5-11 13:44:12 发布方：奥咨达医疗器械咨询美国《联邦规章典集》（CFR）第21篇“食品与药品”总目概述：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（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”（Tit le 21―Food and Drugs）的概况卷（Volume）章（Chapter）部（Parts）规制机关（Regulatory Entity）1 Ⅰ1-99 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）2 100-1693 170-1994 200-2995 300-4996 500-5997 600-7998 800-12999 Ⅱ1300-1399 司法部毒品强制执行局（Drug Enforcement Administration，Department of Justice）Ⅲ1400-1499 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 ADMINIST RATION, 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 REGULATIONS2 一般行政规则与决定GENERAL ADMINISTRATIVE RULINGS AND DECISIONS3 产品管辖权PRODUCT JURISDICTION5 组织ORGANIZATION7 强制执行政策ENFORCEMENT POLICY10 行政规范与程序ADMINISTRATIVE PRACTICES AND PROCEDURES11 电子化记录；电子化签名ELECTRONIC RECORDS; ELECTRONIC SIGNATURES12 正式证据的公众听证FORMAL EVIDENTIARY PUBLIC HEARING13 在公众质询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY14 在公众咨询委员会前的公众听证PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE15 在FDA局长前的公众听证PUBLIC HEARING BEFORE THE COMMISSIONER16 在FDA前的规制性听证REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION17 行政罚款听证CIVIL MONEY PENALTIES HEARINGS19 行为标准与利益冲突STANDARDS OF CONDUCT AND CONFLICTS OF INTEREST20 公共信息PUBLIC INFORMATION21 隐私保护PROTECTION OF PRIVACY25 环境影响考虑ENVIRONMENTAL IMPACT CONSIDERATIONS26 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 COMMUNITY50 人类受试者的保护PROTECTION OF HUMAN SUBJECTS54 临床试验者的财务公开FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS56 机构审查委员会INSTITUTIONAL REVIEW BOARDS58 对非临床实验室研究的良好实验室规范GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES60 专利期恢复PATENT TERM RESTORATION70 色素添加剂COLOR ADDITIVES71 色素添加剂申请COLOR ADDITIVE PETITIONS73 免除认证的色素添加剂的列表LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION74 适用认证的色素添加剂的列表LISTING OF COLOR ADDITIVES SUBJECT TO CERTIFICATION80 色素添加剂认证COLOR ADDITIVE CERTIFICATION81 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 COSMETICS82 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 SPECIFICATIONS83-98 [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GENERAL101 食品标识FOOD LABELING102 非标准化食品的普通的或者通常的名称COMMON OR USUAL NAME FOR NONSTANDARDIZED FOODS104 食品的营养质量指南NUTRITIONAL QUALITY GUIDELINES FOR FOODS105 特殊膳食用途的食品FOODS FOR SPECIAL DIETARY USE106 婴儿配方母乳替代食品质量控制程序INFANT FORMULA QUALITY CONTROL PROCEDURES107 婴儿配方母乳替代食品INFANT FORMULA108 紧急许可控制EMERGENCY PERMIT CONTROL109 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 MATERIAL110 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 FOOD113 装在密封容器中的热加工低酸食品THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS114 酸化食品ACIDIFIED FOODS115 带壳蛋SHELL EGGS119 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 RISK120 危害分析与关键控制点（HACCP）体系HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEMS123 鱼与渔业产品FISH AND FISHERY PRODUCTS129 饮用水加工与装瓶PROCESSING AND BOTTLING OF BOTTLED DRINKING WATER130 食品标准：总则FOOD STANDARDS: GENERAL131 乳与奶油MILK AND CREAM133 乳酪与相关乳酪产品CHEESES AND RELATED CHEESE PRODUCTS135 冷冻点心FROZEN DESSERTS136 烘焙产品BAKERY PRODUCTS137 谷物粉与相关产品CEREAL FLOURS AND RELATED PRODUCTS139 通心粉与面条产品MACARONI AND NOODLE PRODUCTS145 罐装水果CANNED FRUITS146 罐装水果汁CANNED FRUIT JUICES150 水果黄油、果冻、防腐剂以及相关产品FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATED PRODUCTS152 水果馅饼FRUIT PIES155 罐装蔬菜CANNED VEGETABLES156 蔬菜汁VEGETABLE JUICES158 冷冻蔬菜FROZEN VEGETABLES160 蛋与蛋制品EGGS AND EGG PRODUCTS161 鱼与有壳的水生动物FISH AND SHELLFISH163 可可制品CACAO PRODUCTS164 树坚果与花生制品TREE NUT AND PEANUT PRODUCTS165 饮料BEVERAGES166 人造黄油MARGARINE168 增甜剂与餐桌糖浆SWEETENERS AND TABLE SIRUPS169 食品敷料与调味料FOOD DRESSINGS AND FLAVORINGS170 食品添加剂FOOD ADDITIVES171 食品添加剂申请FOOD ADDITIVE PETITIONS172 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 CONSUMPTION173 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 CONSUMPTION174 间接食品添加剂：总则INDIRECT FOOD ADDITIVES: GENERAL175 间接食品添加剂：胶粘剂与涂层的组分INDIRECT FOOD ADDITIVES: ADHESIVES AND COMPONENTS OF COATINGS176 间接食品添加剂：纸与纸板组分INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS177 间接食品添加剂：聚合体INDIRECT FOOD ADDITIVES: POLYMERS178 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 FOOD180 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 STUDY181 先前核准的食品配料PRIOR-SANCTIONED FOOD INGREDIENTS182 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE184 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 FOOD190 膳食补充剂DIETARY SUPPLEMENTS191-199 [预留的] [Reserved]第C分章―药品：总则（SUBCHAPTER C―DRUGS: GENERAL）200 总则GENERAL201 标识LABELING202 处方药广告PRESCRIPTION DRUG ADVERTISING203 处方药销售PRESCRIPTION DRUG MARKETING205 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 DISTRIBUTORS206 人用固体口服剂型药品的印码IMPRINTING OF SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR HUMAN USE207 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 DISTRIBUTION208 处方药的药物治疗指导MEDICATION GUIDES FOR PRESCRIPTION DRUG PRODUCTS210 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; GENERAL211 对完成的药品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED PHARMACEUTICALS216 药房配药PHARMACY COMPOUNDING225 对含药饲料的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICATED FEEDS226 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 DRUGS290 管制的药品CONTROLLED DRUGS299 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GENERAL310 新药NEW DRUGS312 试验用新药申请INVESTIGATIONAL NEW DRUG APPLICATION314 为FDA批准上市新药的申请APPLICATIONS FOR FDA APPROVAL TO MARKET A NEW DRUG315 诊断用放射性药品DIAGNOSTIC RADIOPHARMACEUTICALS316 罕见病药ORPHAN DRUGS320 生物利用度与生物等效性要求BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS328 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 ALCOHOL330 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 MISBRANDED331 用于非处方的人类使用的抗酸产品ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC) HUMAN USE332 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 USE333 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 USE335 用于非处方的人类使用的止泻药品ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE336 用于非处方的人类使用的止吐药品ANTIEMETIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE338 用于非处方的人类使用的帮助夜间睡眠的药品NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE340 用于非处方的人类使用的兴奋药品STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE341 用于非处方的人类使用的感冒、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 USE343 用于非处方的人类使用的内服的止痛、退热以及抗风湿药品INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE344 用于非处方的人类使用的局部的耳部药品TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE346 用于非处方的人类使用的肛肠药品ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE347 用于非处方的人类使用的皮肤保护药品SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE348 用于非处方的人类使用的外部的止痛药品EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE349 用于非处方的人类使用的眼科药品OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE350 用于非处方的人类使用的止汗药品ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE352 用于非处方的人类使用的遮光药品SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]355 用于非处方的人类使用的防龋药品ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE357 用于非处方的人类使用的其他内服药品MISCELLANEOUS INTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE358 用于非处方的人类使用的其他外用药品MISCELLANEOUS EXTERNAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE361 一般认为安全与有效以及不错误标识的处方人用药品：用于研究的药品PRESCRIPTION DRUGS FOR HUMAN USE GENERALLYRECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED: DRUGS USED IN RESEARCH369 在用于非处方销售的药品与器械上关于警告的解释性声明INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND DEVICES FOR OVER-THE-COUNTER SALE370-499 [预留的] [Reserved]第E分章―动物药品、饮料和相关产品（SUB CHAPTER E―ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS）500 总则GENERAL501 动物食品标识ANIMAL FOOD LABELING502 非标准化的动物食品的普通的或通常的名称COMMON OR USUAL NAMES FOR NONSTANDARDIZED ANIMAL FOODS509 在动物食品与食品-包装材料中的不可避免的污染物UNAVOIDABLE CONTAMINANTS IN ANIMAL FOOD AND FOOD-PACKAGING MATERIAL510 新动物药NEW ANIMAL DRUGS511 作为试验用途的新动物药NEW ANIMAL DRUGS FOR INVESTIGATIONAL USE514 新动物药申请NEW ANIMAL DRUG APPLICATIONS515 含药饲料厂执照MEDICATED FEED MILL LICENSE520 口服剂型的新动物药ORAL DOSAGE FORM NEW ANIMAL DRUGS522 植入或者注射剂型的新动物药IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS524 眼科和局部剂型的新动物药OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS526 乳房内的剂型INTRAMAMMARY DOSAGE FORMS529 某些其他剂型的新动物药CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS530 在动物中的特别标签药品使用EXTRALABEL DRUG USE IN ANIMALS556 在食品中新动物药残留的容许量TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD558 用于动物饲料的新动物药NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS564 [预留的] [Reserved]570 食品添加剂FOOD ADDITIVES571 食品添加剂申请FOOD ADDITIVE PETITIONS573 在动物饲料与饮用水中允许的食品添加剂FOOD ADDITIVES PERMITTED IN FEED AND DRINKING WATER OF ANIMALS579 在动物饲料和宠物食品的生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD582 一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE584 在动物饲料与饮用水中被确认为一般认为安全的食品物质FOOD SUBSTANCES AFFIRMED AS GENERALLY RECOGNIZED AS SAFE IN FEED AND DRINKING WATER OF ANIMALS589 禁止用于动物食品或者饲料的物质SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED590-599 [预留的] [Reserved]第F分章―生物制品（SUB CHAPTER F―BIOLOGICS）600 生物制品：总则BIOLOGICAL PRODUCTS: GENERAL601 颁发执照LICENSING606 对血液与血液组分的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR BLOOD AND BLOOD COMPONENTS607 对人类血液与血液制品的制造者的机构登记与产品列表ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS610 普通生物制品标准GENERAL BIOLOGICAL PRODUCTS STANDARDS630 对血液、血液组分和血液衍生物的一般要求GENERAL REQUIREMENTS FOR BLOOD, BLOOD COMPONENTS, AND BLOOD DERIVATIVES640 对人类血液和血液制品的附加标准ADDITIONAL STANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS660 对用于实验室检测的诊断物质的附加标准ADDITIONAL STANDARDS FOR DIAGNOSTIC SUBSTANCES FOR LABORATORY TESTS680 对其他产品的附加标准ADDITIONAL STANDARDS FOR MISCELLANEOUS PRODUCTS第G分章―化妆品（SUBCHAPTER G―COSMETICS）700 总则GENERAL701 化妆品标识COSMETIC LABELING710 化妆品机构的自愿登记VOLUNTARY REGISTRATION OF COSMETIC PRODUCT ESTABLISHMENTS720 化妆品配料构成声明的自愿存档VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT COMPOSITION STATEMENTS740 化妆品警告声明COSMETIC PRODUCT WARNING STATEMENTS741-799 [预留的] [Reserved]第H分章―医疗器械（SUBCHAPTER H―MEDICAL DEVICES）800 总则GENERAL801 标识LABELING803 医疗器械报告MEDICAL DEVICE REPORTING806 医疗器械；改正与移动的报告MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS807 对器械的制造者与首次进口者的机构登记与器械列表ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES808 对州和地方医疗器械要求的联邦优先权的豁免EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS809 人用体外诊断产品IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE810 医疗器械召回权MEDICAL DEVICE RECALL AUTHORITY812 试验用器械豁免INVESTIGATIONAL DEVICE EXEMPTIONS813 [预留的] [Reserved]814 医疗器械的上市前批准PREMARKET APPROVAL OF MEDICAL DEVICES820 质量体系规章QUALITY SYSTEM REGULATION821 医疗器械跟踪要求MEDICAL DEVICE TRACKING REQUIREMENTS822 上市后监视POSTMARKET SURVEILLANCE860 医疗器械分类程序MEDICAL DEVICE CLASSIFICATION PROCEDURES861 性能标准制定程序PROCEDURES FOR PERFORMANCE STANDARDS DEVELOPMENT862 临床化学与临床毒理学器械CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES864 血液学与病理学器械HEMATOLOGY AND PATHOLOGY DEVICES866 免疫学与微生物学器械IMMUNOLOGY AND MICROBIOLOGY DEVICES868 麻醉学器械ANESTHESIOLOGY DEVICES870 心血管器械CARDIOVASCULAR DEVICES872 牙科器械DENTAL DEVICES874 耳、鼻和咽器械EAR, NOSE, AND THROAT DEVICES876 胃肠病学-泌尿学器械GASTROENTEROLOGY-UROLOGY DEVICES878 普通与整形外科器械GENERAL AND PLASTIC SURGERY DEVICES880 普通医院与个人使用器械GENERAL HOSPITAL AND PERSONAL USE DEVICES882 神经学器械NEUROLOGICAL DEVICES884 产科与妇科学器械OBSTETRICAL AND GYNECOLOGICAL DEVICES886 眼科器械OPHTHALMIC DEVICES888 矫形外科器械ORTHOPEDIC DEVICES890 内科学器械PHYSICAL MEDICINE DEVICES892 放射学器械RADIOLOGY DEVICES895 禁止的器械BANNED DEVICES898 电极铅线与患者电缆的性能标准PERFORMANCE STANDARD FOR ELECTRODE LEAD WIRES AND PATIENT CABLES第I分章―乳房造影质量标准法（SUBCHAPTER I―MAMMOGRAPHY QUALITY STANDA RDS ACT）900 乳房造影法MAMMOGRAPHY第J分章―放射学的健康（SUBCHAPTER J―RADIOLOGICAL HEALTH）1000 总则GENERAL1002 记录与报告RECORDS AND REPORTS1003 缺陷与未能守法的通报NOTIFICATION OF DEFECTS OR FAILURE TO COMPLY1004 电子产品的回购、修理或者置换REPURCHASE, REPAIRS, OR REPLACEMENT OF ELECTRONIC PRODUCTS1005 电子产品的进口IMPORTATION OF ELECTRONIC PRODUCTS1010 电子产品的性能标准：总则PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL1020 电离辐射发生产品的性能标准PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS1030 微波与射电频率发生产品的性能标准PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS1040 发光产品的性能标准PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS1050 声波、次声波和超声波发生产品的性能标准PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS第K分章―[预留的]（SUBCHAPTER K―[RESERVED]）第L分章―根据由食品与药品管理局行政执行的某些其他法的规章（SUBCHAPTER L―REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION）1210 根据《联邦进口乳法》的规章REGULATIONS UNDER THE FEDERAL IMPORT MILK ACT1230 根据《联邦腐蚀性毒物法》的规章REGULATIONS UNDER THE FEDERAL CAUSTIC POISON ACT1240 传染病的控制CONTROL OF COMMUNICABLE DISEASES1250 州际运输卫生INTERSTATE CONVEYANCE SANITATION1251-1269 [预留的] [Reserved]1270 预期用于移植的人体组织HUMAN TISSUE INTENDED FOR TRANSPLANTATION1271 人体细胞、组织以及细胞的和基于组织的产品HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS 1272-1299 [预留的] [Reserved]第Ⅱ章―司法部毒品强制执行局（CHAPTER Ⅱ―DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）1300 定义DEFINITIONS1301 管制物质的制造者、分销者和调剂者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND DISPENSERS OF CONTROLLED SUBSTANCES1302 对管制物质的标识与包装要求LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED SUBSTANCES1303 定额QUOTAS1304 登记者的记录与报告RECORDS AND REPORTS OF REGISTRANTS1305 令的格式ORDER FORMS1306 处方PRESCRIPTIONS1307 杂项MISCELLANEOUS1308 管制物质的表SCHEDULES OF CONTROLLED SUBSTANCES1309 表I化学品的制造者、分销者、进口者和出口者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS1310 列入表的化学品和某些机器的记录与报告RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN MACHINES 1311 [预留的] [Reserved]1312 管制物质的进口与出口IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES1313 前体与必要化学品的进口与出口IMPORTATION AND EXPORTATION OF PRECURSORS AND ESSENTIAL CHEMICALS1314-1315 [预留的] [Reserved]1316 行政职能、规范和程序ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES第Ⅲ章―毒品控制政策办公室（CHAPTER Ⅲ―Office of National Drug Control Policy）1400 [预留的] [Reserved]1401 信息的公众可及性PUBLIC AVAILABILITY OF INFORMATION1402 强制性解密审查MANDATORY DECLASSIFICATION REVIEW1403 对给予州和地方政府资金和合作协议的统一行政要求UNIFORM ADMINISTRATIVE REQUIREMENTS FOR GRANTS AND COOPERATIVE AGREEMENTS TO STATE AND LOCAL GOVERNMENTS1404 政府范围的排除与暂停（非获得）GOVERNMENTWIDE DEBARMENT AND SUSPENSION (NONPROCUREMENT)1405 对无毒品工作场所的政府范围的要求（财政援助）GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)1406-1499 [预留的] [Reserved]。

21 CFR § 820Quality System Regulation质量体系手册Subpart A—General ProvisionsA部分——总则820.1 Scope.820.1范围820.3 Definitions.定义820.5 Quality system.质量体系Subpart B—Quality System RequirementsB部分——质量体系要求820.20 Management responsibility.管理者职责820.22 Quality audit.质量审核820.25 Personnel.职员Subpart C—Design ControlsC部分——设计控制820.30 Design controls.设计控制Subpart D—Document ControlsD部分——文件控制820.40 Document controls.文件控制Subpart E—Purchasing ControlsE部分——采购控制820.50 Purchasing controls.采购控制Subpart F—Identification and Traceability F部分——标识和可追溯性820.60 Identification.标识820.65 Traceability.可追溯性Subpart G—Production and Process ControlsG部分——生产和过程控制820.70 Production and process controls.产品和过程控制820.72Inspection,measuring, and test equipment.检查、测量，测试仪器820.75 Process validation.过程确认Subpart H—Acceptance ActivitiesH部分—接收活动820.80 Receiving, in-process, and finished device acceptance.接收设备准则，过程设备准则，最终设备准则820.86 Acceptance status.接收状态Subpart I—Nonconforming ProductI部分——不合格产品820.90 Nonconforming product.不合格产品Subpart J—Corrective and Preventive ActionJ部分——纠正预防措施820.100 Corrective and preventive action.纠正预防措施Subpart K—Labeling and Packaging ControlK部分——标签与包装控制820.120 Device labeling.产品标识820.130 Device packaging.产品包装Subpart L—Handling, Storage, Distribution, and InstallationL部分——操作、存储、分配以及安装820.140 Handling.操作820.150 Storage.存储820.160 Distribution.分配820.170 Installation.安装Subpart M—RecordsM部分——记录820.180 General requirements.总要求820.181 Device master record.产品控制记录820.184 Device history record.产品历史记录820.186 Quality system record.质量体系记录820.198 Complaint files.客户抱怨文件Subpart N—Servicing820.200 Servicing.Subpart O—Statistical Techniques 820.250 Statistical techniques.Authority: Secs. 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383).Subpart A—General Provisions (4)§ 820.1 Scope. (4)Subpart A—General Provisions§ 820.1 Scope.820.1范围(a) Applicability.适用性(1) Current good manufacturing practice (CGMP) requirements are set forth inthis quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements in this part are intended to ensure that finished devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act (the act). This part establishes basic requirements applicable to manufacturers of finished medical devices. If a manufacturer engages in only some operations subject toof finished devices, but such manufacturers are encouraged to use appropriate provisions of this regulation as guidance. Manufacturers of human blood and blood components are not subject to this part, but are subject to part 606 of this chapter.在本质量体系法规（QSR）中阐述了CGMP的要求。

质量体系记录
820.198 Complaint files.
客户抱怨文件
Subpart N—Servicing
820.200 Servicing.
Subpart O—Statistical Techniques
820.250 Statistical techniques.
Authority: Secs. 501, 502, 510, 513, 514, 515, 518, 519, 520, 522, 701, 704, 801, 803 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h, 360i, 360j, 360l, 371, 374, 381, 383).
产品包装
Subpart L—Handling, Storage, Distribution, and Installation
L部分——操作、存储、分配以及安装
820.140 Handling.
操作
820.150 Storage.
存储
820.160 Distribution.
分配
820.170 Installation.
设计控制
Subpart D—Document Controls
D部分——文件控制
820.40 Document controls.
文件控制
Subpart E—Purchasing Controls
E部分——采购控制
820.50 Purchasing controls.
采购控制
Subpart F—Identification and Traceability

美国《联邦规章典集》（CFR）第21篇“食品与药品”总目概述：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（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）INVESTIGATORS56机构审查委员会INSTITUTIONAL REVIEW BOARDS58对非临床实验室研究的良好实验室规范GOOD LABORATORY PRACTICE FOR NONCLINICALLABORATORY STUDIES60专利期恢复PATENT TERM RESTORATION70色素添加剂COLOR ADDITIVES71色素添加剂申请COLOR ADDITIVE PETITIONS73免除认证的色素添加剂的列表LISTING OF COLOR ADDITIVES EXEMPT FROMCERTIFICATION74适用认证的色素添加剂的列表LISTING OF COLOR ADDITIVES SUBJECT TOCERTIFICATION80色素添加剂认证COLOR ADDITIVE CERTIFICATION81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 GENERALRESTRICTIONS FOR PROVISIONAL COLOR ADDITIVESFOR USE IN FOODS, DRUGS, AND COSMETICS82经认证的临时性列表的色素和规范的列表LISTING OF CERTIFIED PROVISIONALLY LISTEDCOLORS AND SPECIFICATIONS83-98[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 ONUNAPPROVED/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GENERAL101食品标识FOOD LABELING102非标准化食品的普通的或者通常的名称COMMON OR USUAL NAME FOR NONSTANDARDIZEDFOODS104食品的营养质量指南NUTRITIONAL QUALITY GUIDELINES FOR FOODS105特殊膳食用途的食品FOODS FOR SPECIAL DIETARY USE106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 FORMULA108紧急许可控制EMERGENCY PERMIT CONTROL109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 FORHUMAN CONSUMPTION AND FOOD-PACKAGINGMATERIAL110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 INMANUFACTURING, PACKING, OR HOLDING HUMANFOOD113装在密封容器中的热加工低酸食品THERMALLY PROCESSED LOW-ACID FOODSPACKAGED IN HERMETICALLY SEALED CONTAINERS 114酸化食品ACIDIFIED FOODS115带壳蛋SHELL EGGS119存在显著或者不合理风险的膳食补充剂DIETARY SUPPLEMENTS THAT PRESENT ASIGNIFICANT OR UNREASONABLE RISK120危害分析与关键控制点（HACCP）体系HAZARD ANALYSIS AND CRITICAL CONTROL POINT(HACCP) SYSTEMS123鱼与渔业产品FISH AND FISHERY PRODUCTS129饮用水加工与装瓶PROCESSING AND BOTTLING OF BOTTLED DRINKINGWATER130食品标准：总则FOOD STANDARDS: GENERAL131乳与奶油MILK AND CREAM133乳酪与相关乳酪产品CHEESES AND RELATED CHEESE PRODUCTS135冷冻点心FROZEN DESSERTS136烘焙产品BAKERY PRODUCTS137谷物粉与相关产品CEREAL FLOURS AND RELATED PRODUCTS139通心粉与面条产品MACARONI AND NOODLE PRODUCTS145罐装水果CANNED FRUITS146罐装水果汁CANNED FRUIT JUICES150水果黄油、果冻、防腐剂以及相关产品FRUIT BUTTERS, JELLIES, PRESERVES, AND RELATEDPRODUCTS152水果馅饼FRUIT PIES155罐装蔬菜CANNED VEGETABLES156蔬菜汁VEGETABLE JUICES158冷冻蔬菜FROZEN VEGETABLES160蛋与蛋制品EGGS AND EGG PRODUCTS161鱼与有壳的水生动物FISH AND SHELLFISH163可可制品CACAO PRODUCTS164树坚果与花生制品TREE NUT AND PEANUT PRODUCTS 165饮料BEVERAGES166人造黄油MARGARINE168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 ADDITIVES171食品添加剂申请FOOD ADDITIVE PETITIONS172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 CONSUMPTION173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 CONSUMPTION174间接食品添加剂：总则INDIRECT FOOD ADDITIVES: GENERAL175间接食品添加剂：胶粘剂与涂层的组分INDIRECT FOOD ADDITIVES: ADHESIVES ANDCOMPONENTS OF COATINGS176间接食品添加剂：纸与纸板组分INDIRECT FOOD ADDITIVES: PAPER ANDPAPERBOARD COMPONENTS177间接食品添加剂：聚合体INDIRECT FOOD ADDITIVES: POLYMERS178间接食品添加剂：辅剂、生产助剂和消毒剂INDIRECT FOOD ADDITIVES: ADJUVANTS,PRODUCTION AIDS, AND SANITIZERS179在食品生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING ANDHANDLING OF FOOD180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 INCONTACT WITH FOOD ON AN INTERIM BASISPENDING ADDITIONAL STUDY181先前核准的食品配料PRIOR-SANCTIONED FOOD INGREDIENTS182一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE184被确认为一般认为安全的直接食品物质DIRECT FOOD SUBSTANCES AFFIRMED ASGENERALLY 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 ASGENERALLY RECOGNIZED AS SAFE 189禁止用于人类食品的物质SUBSTANCES PROHIBITED FROM USE IN HUMANFOOD190膳食补充剂DIETARY SUPPLEMENTS191-199[预留的][Reserved]第C分章—药品：总则（SUBCHAPTER C—DRUGS: GENERAL）200总则GENERAL201标识LABELING202处方药广告PRESCRIPTION DRUG ADVERTISING203处方药销售PRESCRIPTION DRUG MARKETING205对批发处方药销售商颁发州执照的指南GUIDELINES FOR STATE LICENSING OF WHOLESALEPRESCRIPTION DRUG DISTRIBUTORS 206人用固体口服剂型药品的印码IMPRINTING OF SOLID ORAL DOSAGE FORM DRUGPRODUCTS FOR HUMAN USE207药品生产者的登记与商业销售的药品的列表REGISTRATION OF PRODUCERS OF DRUGS ANDLISTING OF DRUGS IN COMMERCIAL DISTRIBUTION 208处方药的药物治疗指导MEDICATION GUIDES FOR PRESCRIPTION DRUGPRODUCTS210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 INMANUFACTURING, PROCESSING, PACKING, ORHOLDING OF DRUGS; GENERAL211药品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FORFINISHED PHARMACEUTICALS216药房配药PHARMACY COMPOUNDING225对含药饲料的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FORMEDICATED FEEDS226对A型含药物品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FORTYPE A MEDICATED ARTICLES250对特殊人用药品的特殊要求SPECIAL REQUIREMENTS FOR SPECIFIC HUMANDRUGS290管制的药品CONTROLLED DRUGS299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GENERAL310新药NEW DRUGS312试验用新药申请INVESTIGATIONAL NEW DRUG APPLICATION314为FDA批准上市新药的申请APPLICATIONS FOR FDA APPROVAL TO MARKET ANEW DRUG315诊断用放射性药品DIAGNOSTIC RADIOPHARMACEUTICALS316罕见病药ORPHAN DRUGS320生物利用度与生物等效性要求BIOAVAILABILITY AND BIOEQUIVALENCEREQUIREMENTS328含有酒精的预期用于口部摄入的非处方药品OVER-THE-COUNTER DRUG PRODUCTS INTENDEDFOR ORAL INGESTION THAT CONTAIN ALCOHOL330一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 WHICHARE GENERALLY RECOGNIZED AS SAFE ANDEFFECTIVE AND NOT MISBRANDED331用于非处方的人类使用的抗酸产品ANTACID PRODUCTS FOR OVER-THE-COUNTER (OTC)HUMAN USE332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 USE333用于非处方的人类使用的局部抗菌药品TOPICAL ANTIMICROBIAL DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE335用于非处方的人类使用的止泻药品ANTIDIARRHEAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USECOUNTER HUMAN USE338用于非处方的人类使用的帮助夜间睡眠的药品NIGHTTIME SLEEP-AID DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE340用于非处方的人类使用的兴奋药品STIMULANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE341用于非处方的人类使用的感冒、咳嗽、过敏症药、支气管扩张以及平喘药品COLD, COUGH, ALLERGY, BRONCHODILATOR, ANDANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE343用于非处方的人类使用的内服的止痛、退热以及抗风湿药品INTERNAL ANALGESIC, ANTIPYRETIC, ANDANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE344用于非处方的人类使用的局部的耳部药品TOPICAL OTIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE346用于非处方的人类使用的肛肠药品ANORECTAL DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE347用于非处方的人类使用的皮肤保护药品SKIN PROTECTANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE348用于非处方的人类使用的外部的止痛药品EXTERNAL ANALGESIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE349用于非处方的人类使用的眼科药品OPHTHALMIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE350用于非处方的人类使用的止汗药品ANTIPERSPIRANT DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE352用于非处方的人类使用的遮光药品SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE [STAYED INDEFINITELY]355用于非处方的人类使用的防龋药品ANTICARIES DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE357用于非处方的人类使用的其他内服药品MISCELLANEOUS INTERNAL DRUG PRODUCTS FOROVER-THE-COUNTER HUMAN USE564[预留的][Reserved]570食品添加剂FOOD ADDITIVES571食品添加剂申请FOOD ADDITIVE PETITIONS573在动物饲料与饮用水中允许的食品添加剂FOOD ADDITIVES PERMITTED IN FEED AND DRINKINGWATER OF ANIMALS579在动物饲料和宠物食品的生产、加工和处理中的辐照IRRADIATION IN THE PRODUCTION, PROCESSING, AND HANDLING OF ANIMAL FEED AND PET FOOD582一般认为安全的物质SUBSTANCES GENERALLY RECOGNIZED AS SAFE584在动物饲料与饮用水中被确认为一般认为安全的食品物质FOOD SUBSTANCES AFFIRMED AS GENERALLYRECOGNIZED AS SAFE IN FEED AND DRINKINGWATER OF ANIMALS589禁止用于动物食品或者饲料的物质SUBSTANCES PROHIBITED FROM USE IN ANIMALFOOD OR FEED590-599[预留的][Reserved]第F分章—生物制品（SUBCHAPTER F—BIOLOGICS）600生物制品：总则BIOLOGICAL PRODUCTS: GENERAL601颁发执照LICENSING606对血液与血液组分的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FORBLOOD AND BLOOD COMPONENTS607对人类血液与血液制品的制造者的机构登记与产品列表ESTABLISHMENT REGISTRATION AND PRODUCTLISTING FOR MANUFACTURERS OF HUMAN BLOODAND BLOOD PRODUCTS610普通生物制品标准GENERAL BIOLOGICAL PRODUCTS STANDARDS630对血液、血液组分和血液衍生物的一般要求GENERAL REQUIREMENTS FOR BLOOD, BLOODCOMPONENTS, AND BLOOD DERIVATIVES640对人类血液和血液制品的附加标准ADDITIONAL STANDARDS FOR HUMAN BLOOD ANDBLOOD PRODUCTS660对用于实验室检测的诊断物质的附加标准ADDITIONAL STANDARDS FOR DIAGNOSTICSUBSTANCES FOR LABORATORY TESTS680对其他产品的附加标准ADDITIONAL STANDARDS FOR MISCELLANEOUSPRODUCTS第G分章—化妆品（SUBCHAPTER G—COSMETICS）700总则GENERAL701化妆品标识COSMETIC LABELING710化妆品机构的自愿登记VOLUNTARY REGISTRATION OF COSMETIC PRODUCTESTABLISHMENTS720化妆品配料构成声明的自愿存档VOLUNTARY FILING OF COSMETIC PRODUCTINGREDIENT COMPOSITION STATEMENTS 740化妆品警告声明COSMETIC PRODUCT WARNING STATEMENTS741-799[预留的][Reserved]第H分章—医疗器械（SUBCHAPTER H—MEDICAL DEVICES）800总则GENERAL801标识LABELING803医疗器械报告MEDICAL DEVICE REPORTING806医疗器械；改正与移动的报告MEDICAL DEVICES; REPORTS OF CORRECTIONS ANDREMOVALS807对器械的制造者与首次进口者的机构登记与器械列表ESTABLISHMENT REGISTRATION AND DEVICELISTING FOR MANUFACTURERS AND INITIALIMPORTERS OF DEVICES808对州和地方医疗器械要求的联邦优先权的豁免EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL MEDICAL DEVICE REQUIREMENTS809人用体外诊断产品IN VITRO DIAGNOSTIC PRODUCTS FOR HUMAN USE 810医疗器械召回权MEDICAL DEVICE RECALL AUTHORITY812试验用器械豁免INVESTIGATIONAL DEVICE EXEMPTIONS813[预留的][Reserved]814医疗器械的上市前批准PREMARKET APPROVAL OF MEDICAL DEVICES 820质量体系规章QUALITY SYSTEM REGULATION821医疗器械跟踪要求MEDICAL DEVICE TRACKING REQUIREMENTS822上市后监视POSTMARKET SURVEILLANCE860医疗器械分类程序MEDICAL DEVICE CLASSIFICATION PROCEDURESDEVELOPMENT临床化学与临床毒理学器械CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY 862DEVICES864血液学与病理学器械HEMATOLOGY AND PATHOLOGY DEVICES866免疫学与微生物学器械IMMUNOLOGY AND MICROBIOLOGY DEVICES868麻醉学器械ANESTHESIOLOGY DEVICES870心血管器械CARDIOVASCULAR DEVICES872牙科器械DENTAL DEVICES874耳、鼻和咽器械EAR, NOSE, AND THROAT DEVICES876胃肠病学-泌尿学器械GASTROENTEROLOGY-UROLOGY DEVICES878普通与整形外科器械GENERAL AND PLASTIC SURGERY DEVICES880普通医院与个人使用器械GENERAL HOSPITAL AND PERSONAL USE DEVICES 882神经学器械NEUROLOGICAL DEVICES884产科与妇科学器械OBSTETRICAL AND GYNECOLOGICAL DEVICES886眼科器械OPHTHALMIC DEVICES888矫形外科器械ORTHOPEDIC DEVICES890内科学器械PHYSICAL MEDICINE DEVICES892放射学器械RADIOLOGY DEVICES895禁止的器械BANNED DEVICES电极铅线与患者电缆的性能标准PERFORMANCE STANDARD FOR ELECTRODE LEAD 898WIRES AND PATIENT CABLES第I分章—乳房造影质量标准法（SUBCHAPTER I—MAMMOGRAPHY QUALITY STANDARDS ACT）900乳房造影法MAMMOGRAPHY第J分章—放射学的健康（SUBCHAPTER J—RADIOLOGICAL HEALTH）1000总则GENERAL1002记录与报告RECORDS AND REPORTS1003缺陷与未能守法的通报NOTIFICATION OF DEFECTS OR FAILURE TO COMPLYELECTRONIC PRODUCTS1005电子产品的进口IMPORTATION OF ELECTRONIC PRODUCTS1010电子产品的性能标准：总则PERFORMANCE STANDARDS FOR ELECTRONICPRODUCTS: GENERAL1020电离辐射发生产品的性能标准PERFORMANCE STANDARDS FOR IONIZINGRADIATION EMITTING PRODUCTS 1030微波与射电频率发生产品的性能标准PERFORMANCE STANDARDS FOR MICROWAVE ANDRADIO FREQUENCY EMITTING PRODUCTS 1040发光产品的性能标准PERFORMANCE STANDARDS FOR LIGHT-EMITTINGPRODUCTS1050声波、次声波和超声波发生产品的性能标准PERFORMANCE STANDARDS FOR SONIC, INFRASONIC,AND ULTRASONIC RADIATION-EMITTING PRODUCTS 第K分章—[预留的]（SUBCHAPTER K—[RESERVED]）第L分章—根据由食品与药品管理局行政执行的某些其他法的规章（SUBCHAPTER L—REGULATIONS UNDER CERTAIN OTHER ACTS ADMINISTERED BY THE FOOD AND DRUG ADMINISTRATION）1210根据《联邦进口乳法》的规章REGULATIONS UNDER THE FEDERAL IMPORT MILKACT1230根据《联邦腐蚀性毒物法》的规章REGULATIONS UNDER THE FEDERAL CAUSTICPOISON ACT1240传染病的控制CONTROL OF COMMUNICABLE DISEASES1250州际运输卫生INTERSTATE CONVEYANCE SANITATION 1251-1269[预留的][Reserved]1270预期用于移植的人体组织HUMAN TISSUE INTENDED FOR TRANSPLANTATION1271人体细胞、组织以及细胞的和基于组织的产品HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS1272-1299[预留的][Reserved]第Ⅱ章—司法部毒品强制执行局（CHAPTER Ⅱ—DRUG ENFORCEMENT ADMINISTRATION, DEPARTMENT OF JUSTICE）1300定义DEFINITIONSAND DISPENSERS OF CONTROLLED SUBSTANCES 1302对管制物质的标识与包装要求LABELING AND PACKAGING REQUIREMENTS FORCONTROLLED SUBSTANCES1303定额QUOTAS1304登记者的记录与报告RECORDS AND REPORTS OF REGISTRANTS1305令的格式ORDER FORMS1306处方PRESCRIPTIONS1307杂项MISCELLANEOUS1308管制物质的表SCHEDULES OF CONTROLLED SUBSTANCES1309表I化学品的制造者、分销者、进口者和出口者的登记REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS AND EXPORTERS OF LIST I CHEMICALS1310列入表的化学品和某些机器的记录与报告RECORDS AND REPORTS OF LISTED CHEMICALS ANDCERTAIN MACHINES1311[预留的][Reserved]1312管制物质的进口与出口IMPORTATION AND EXPORTATION OF CONTROLLEDSUBSTANCES1313前体与必要化学品的进口与出口IMPORTATION AND EXPORTATION OF PRECURSORSAND ESSENTIAL CHEMICALS 1314-1315[预留的][Reserved]1316行政职能、规范和程序ADMINISTRATIVE FUNCTIONS, PRACTICES, ANDPROCEDURES第Ⅲ章—毒品控制政策办公室（CHAPTER Ⅲ—Office of National Drug Control Policy）1400[预留的][Reserved]1401信息的公众可及性PUBLIC AVAILABILITY OF INFORMATION1402强制性解密审查MANDATORY DECLASSIFICATION REVIEW1403对给予州和地方政府资金和合作协议的统一行政要求UNIFORM ADMINISTRATIVE REQUIREMENTS FORGRANTS AND COOPERATIVE AGREEMENTS TO STATEAND LOCAL GOVERNMENTS1404政府范围的排除与暂停（非获得）GOVERNMENTWIDE DEBARMENT AND SUSPENSION(NONPROCUREMENT)1405对无毒品工作场所的政府范围的要求（财政援助）GOVERNMENTWIDE REQUIREMENTS FOR DRUG-FREE WORKPLACE (FINANCIAL ASSISTANCE)1406-1499[预留的][Reserved]。

FDA21CFRpart11译⽂21 CFR Part 11是针对电⼦记录和电⼦签名的FDA法规，对于药⼚和医疗器械使⽤的众多电⼦记录和电⼦签名提供了详尽的要求和规范。

彼得对这部分接触的也不多，在研读过程中将原⽂进⾏了翻译，供⼤家交流和讨论。

A部分—通⽤规定Subpart A--General Provisions11.1 范围Sec. 11.1 Scope.(a) 本部分的法规制定了接受标准，⽤于机构评估电⼦记录、电⼦签名、电⼦记录加⼿写签名的可信性、可靠性，以及通常等同于纸质记录和⼿写签名的形式。

(a) The regulations in this part setforth the criteria under which the agency considers electronic records,electronic signatures, and handwritten signatures executed to electronicrecords to be trustworthy, reliable, and generally equivalent to paper recordsand handwritten signatures executed on paper.(b) 本部分适⽤于根据法规需求制定的，以电⼦形式⽣成、修改、维护、存档、恢复或传输的任何记录。

还适⽤于提交给监管机构的关于联邦⾷品、药品和化妆品以及公共健康服务法案需求的电⼦记录，即使此类记录不是法规中特别提到的。

但是，本部分不适⽤于以电⼦形式传输的纸质记录。

(b) This part applies to records inelectronic form that are created, modified, maintained, archived, retrieved, ortransmitted, under any records requirements set forth in agency regulations.This part also applies to electronic records submitted to the agency underrequirements of the Federal Food, Drug, and Cosmetic Act and the Public HealthService Act, even if such records are not specifically identified in agencyregulations. However, this part does not apply to paper records that are, orhave been, transmitted by electronic means.(c) 当电⼦签名和相关的电⼦记录符合本部分要求时，机构应认可电⼦签名等同于⼿写签名、缩写和其他法规中要求常⽤的签名形式，除⾮是法规⾃1997年8⽉20⽇以来特别强调的情况。