美国联邦法规(FDA 21CFR Part 601 LICENSING)

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21 CFR Part 11 联邦法规21章第11款主要规定内容涉及电子记录和电子签名

21 CFR Part 11 联邦法规21章第11款主要规定内容涉及电子记录和电子签名适用范围(a) 本条款的规则提供了标准，在此标准之下FDA将认为电子记录、电子签名、和在电子记录上的手签名是可信赖的、可靠的并且通常等同于纸制记录和在纸上的手写签名。

(b) 本条款适用于在FDA规则中阐明的在任何记录的要求下，以电子表格形式建立、修改、维护、归档、检索或传送的记录。

本条款同样适用于在《联邦食品、药品和化妆品法案》和《公众健康服务法案》要求下的呈送给FDA的电子记录，即使该记录没有在FDA规则下明确识别。

然而，本条款不适用于现在和已经以电子的手段传送的纸制记录。

除非被从1997年8月20日起（包括该日）生效后的规则明确地排除在外。

(d) 依照本条款11.2，除非纸制记录有特殊的要求，符合本条款要求的电子记录可以代替纸制记录使用。

(e) 在本条款下维护计算机系统（包括硬件和软件）、控制权、和随附的文件应便于被FDA用到，和服从于FDA的监管。

履行(a) 需要维护，但不提交给FDA的记录，如果符合本条款的要求,人们可以使用全部或部分电子记录代替纸制记录或用电子签名代替传统签名。

(b)提交给FDA的电子记录，人们可以使用全部或部分电子记录代替纸制记录或电子签名代替传统签名（手签名）假如：(1) 符合条款的要求(2) 提交的文件或部分文件，作为FDA以电子形式接收的提交物的类型已经被编号为92S-0251公共摘要识别出来。

这个摘要将明确地识别出，何种类型文件或部分文件在没有纸制记录和FDA接收单位(举例来说，特定的中心，办公室，部门、分支机构)时的电子形式提交物是可接受的。

如果没有在公共摘要上明确出来，他们以电子形式提交给FDA接收单位的文件将不被认为是正式的；这种文件的书面形式将被认为是正式的但必须伴有电子记录。

法规解析：什么是 FDA 21 CFR Part 11？

法规解析：什么是FDA 21 CFR Part 11？美国FDA于1997年颁布21 CFRPart 11，并于2003年颁布相关行业指南来细化有关规则。

在Part11规定中，电子记录被认为具有与书面记录和手写签名同等的效力。

21CFRPart 11被美国的生物医药企业、医院、研究所和实验室广泛接受和遵照执行。

自颁布以来已被推广至全球，虽然没有强制性，但被欧洲、亚洲等地图和国家普遍接受和使用。

美国作为全球生物医药产业最主要组成部分影响力巨大，当你的药物、生物医药相关设备或者信息系统需要销售给美国的制药企业和研究人员都应该符合21 CFR Part 11的规定。

如违反，FDA能够根据规定剥夺出口到美国的权利。

其他国家对电子记录和电子签名也有类似要求，会以21 CFRPart 11的相关规定为指导原则，来制定本国的相关法规。

我国目前暂无像21CFR Part 11这样在生物医药领域针对电子记录和电子签名的规范或标准。

我国在2005年开始实施了《中华人民共和国电子签名法》，但这主要针对容易引起法律纠纷如合同、协议等的电子签名有效性的规定。

当前在GCP领域对中国来说，困扰的问题不仅在于你选择应用的信息系统是否适用于21CFR规定及是否验证，还在于如何建立一套较完善的实施GCP电子记录管理体系和电子签名有效性管理规范何时落地。

一、21 CFRPart 11涉及领域广泛(共有1499个部分)21CFR=Food and Drugs21CFR58=GLP21CFR210=GMP, Drugs (General)21CFR211=GMP, Drugs (Finished Pharmaceuticals)21CFR312=Inv. New drug Application (GCP)21CFR314=FDA Approval of new drug (GCP)21CFR6xx=GMP, biologics21CFR820=GMP, Devices21CFR…= Food, nutrients and cosmetics21CFR11=Electronic Records; Electronic Signatures其中在GCP领域主要包括中心实验室建设、数据获取和报告、远程数据录入、CRF体系、临床数据管理、AE报告、临床支持体系和统计分析体系。

（完整版）美国FDA《联邦规章典集》（CFR）第21篇目录中文版

（完整版）美国FDA《联邦规章典集》（CFR）第21篇目录中文版美国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 EnforcementAdministration，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 Drug s）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 RESTRICTIONSFOR 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 USE 106 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 FOOD 113 装在密封容器中的热加工低酸食品THERMALLYPROCESSED 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 PRODUCTS 145 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 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 AND COMPONENTS OF COATINGS 176 间接食品添加剂：纸与纸板组分INDIRECT FOOD ADDITIVES: PAPER AND PAPERBOARD COMPONENTS 177 间接食品添加剂：聚合体INDIRECT FOOD ADDITIVES: 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 FOOD 180 在额外试验期间临时在食品或者在与食品接触中被允许的食品添加剂FOOD ADDITIVES PERMITTED IN FOOD OR IN CONTACT WITH FOOD ON AN INTERIM BASIS PENDING ADDITIONALSTUDY181 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 USE 207 药品生产者的登记与商业销售的药品的列表REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS IN COMMERCIAL 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 INMANUFACTURING, 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 FEEDS 226 对A型含药物品的现行良好制造规范CURRENT GOOD MANUFACTURING PRACTICE FOR TYPE A MEDICATED ARTICLES 250 对特殊人用药品的特殊要求SPECIAL REQUIREMENTS FOR SPECIFIC HUMAN 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 INGESTIONTHAT 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 USE 344 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 USE 348 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 GENERALLY RECOGNIZED 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 FOODS 509 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 ANIMALS 579 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 PRODUCTS 610 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ADDITIONALSTANDARDS FOR HUMAN BLOOD AND BLOOD PRODUCTS 660 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―COSMETIC S）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 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 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 DEVICES 808 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 EXEMPTIONS 813 [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 PRODUCTS 1030 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 FORLIGHT-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 DISEASES 1250 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 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 SUBSTANCES 1303 定额QUOTAS1304 登记者的记录与报告RECORDS AND REPORTS OFREGISTRANTS1305 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 CHEMICALS 1314-1315 [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]。

支持21CFRPart11和附录11的法规要求

概述美国联邦法规 (CFR) US FDA 第 21 章 Part 11 及其类似条款欧盟 Eudralex 第 4 章附录 11 中，介绍了受监管医药组织电子记录和电子签名的要求。

21 CFR Part11 于 1997 年公布，自 1999 年起施行。

实施这些准则的目的是为确保所有合适的电子记录有因可循、清晰易懂、同步记录、原始、准确并且保存完整。

本白皮书为自身组织必须符合这些规范的 Agilent OpenLAB CDS 2.2 版系统用户提供了有用的资源。

OpenLAB CDS 控制对 LC 、GC 、单四极杆 LC/MS和 GC/MS 以及 A/D 数据的采集和处理。

用户及其组织负责确保 OpenLAB CDS 提供的功能使用得当，从而实现实验数据采集和处理的合规操作。

除了 OpenLAB CDS 提供的技术控制之外，用户组织还须建立过程控制，即标准操作规程 (SOP)，以满足相关的非技术性要求。

例如，还须建立内部审计程序等控制措施，确保系统操作人员遵循 SOP 。

附录 1 详细介绍 OpenLAB CDS 2.2 版如何支持用户及其组织，以达到 21 CFR Part 11 各章节以及欧盟附录 11 相关各章节的要求。

该说明假定系统访问（包括仪器硬件和软件）由负责系统所含电子记录的工作人员控制。

因此，系统按照 21 CFR Part 11.3(b)(4) 的定义设计为“封闭系统”。

支持 21 CFR Part 11和附录 11 的法规要求： Agilent OpenLAB CDS 2.2 版白皮书工作归因工作归因指记录执行工作的“人员、内容、时间、位置及原因”。

自动化审核追踪可独立记录用户操作，从而将实验室工作人员与其执行的工作联系起来。

通过审核追踪条目，工作人员和监管人员能够重建电子记录的完整历史。

• 人员：明确指出负责创建、修改或删除记录的特定操作的人员• 内容：指所执行的操作，包括记录中所含的旧值和新值（如果适用）• 时间：明确声明操作发生的日期和时间• 位置：明确指出受影响的记录• 原因：解释变更受监管记录的原因。

针对21CFRPart820法规的讲解

针对21 CFR Part 820法规的讲解一、FDA的定义FDA（U.S. Food and Drug Administration）的简称，即美国食品药品监督管理局。

它是健康与人类服务部下属的一个机构，由各个中心、办公室、地区办公室以及海外办公室组成。

二、联邦法规条例，第21册相关法规说明21 CFR Part 11 电子签名、电子记录（FDA检查时尽量避免给电子档文件）。

21 CFR Part 71.73.74.80 颜色添加剂。

21 CFR Part 58 良好的实验室规范。

21 CFR Part 50 受试者的保护。

21 CFR Part 801 医疗器械标识。

21 CFR Part 807 注册、列示、510（K）510（K）主要是针对产品的许可，包括了产品的生产商、配件生产商、一级销售商，任何一个独立地址的生产厂都必须向FDA注册。

列示：是指针对销售美国的所有产品都要列示。

21 CFR Part 814 上市前许可。

21 CFR Part 803 医疗器械报告。

21 CFR Part 806 纠正与移除。

21 CFR Part 820 质量体系法规。

21 CFR Part 821 医疗器械追踪。

三、第820部分质量体系法规条款框架（共15部分，31章节）（a）适用性（b）法规说明820.1范围（c）权威性（d）外国制造商A部分总则（e）豁免或改变820.3定义820.5质量体系（a）质量方针（1）职责和权限（b）组织（2）资源820.30管理职责（c）管理评审（3）管理者代表B部分质量体系要求820.22质量审核（d）质量策划（e）质量体系程序820.25人员（a）总则（b）培训（a）总则（b）设计和开发策划（c）设计输入（d）设计输出（e）设计评审C部分设计控制----- 820.30设计控制（f）设计验证（g）设计确认（h）设计转换（i）设计更改（j）设计历史文档（a）文件批准和分发D部分文件控制----- 820.40文件控制（b）文件更改（a）采购、承包方和顾问的评价E部分采购控制----- 820.50采购控制（b）采购资料820.60标识F部分标识和可追溯性820.65 可追溯性（a）总则（b）生产和过程更改（c）环境控制（d）人员820.70 生产和过程控制（e）污染控制（f）建筑物1）维护计划（g）设备（2）检查（h）制造物料（3）调整（i）自动化过程G部分生产和过程控制（a）检验、测量和试验装置控制820.72校验、测量和试验装置（1）校准标准（b）校准（2）校准记录820.75过程确认（a）总则（b）进货验收活动820.80 进货、过程中和成品（c）过程中验收活动器械的验收（d）最终验收活动H部分验收活动（e）验收记录820.86 验收状态（a）不合格产品控制I部分不合格产品------ 820.90 不合格产品（b）不合格评审和处置J部分纠正和预防措施----820.100纠正和预防措施（a）标签完整性（b）标记检验820.120 器械标识（c）标识存储K部分标识和包装控制（d）标签作业820.130 器械包装（e）控制号820.140 搬运（a）对存储区规定文件820.150 存储L部分搬运、存储、分销和包装820.160 分销（b）物料收发方法规定文件820.170 安装（a）机密性820.180 通用要求（b）记录保存期限（1）管理评审（c）例外（2）质量审核（a）器械规范（3）供方审核（b）生产过程规范820.181 器械主记录（c）质量保证程序和规范（d）包装和标识规范（e）安装、维护和服务程序及方法（a）制造日期M部分记录（b）制造数量820.184器械的历史记录（c）放行分销的数量（d）验收记录（e）器械上的主要标签和标识记录（f）器械唯一标识UDI和产品代码UPC820.186 质量体系记录1、抱怨接收流程820.198 抱怨文档2、抱怨评估流程3、抱怨审核流程N部分服务----- 820.200 服务O部分统计技术----- 820.250 统计技术。

美国法典简介-21 CFR结构内容

21 CFR结构内容在美国，参议员或众议员每年都会提出很多议案（bill）。

议案交由委员会审议修订，然后在国会议院投票，一院投票通过后，送交另一院，两院通过后交总统签署；若总统不否决，或虽否决但经两院2/3议员重新通过，即正式成为法律（law）。

法律规定了基本的准则，并由联邦政府执行机构根据具体的法规（Regulation）来执行。

《美国联邦法规》（Code of FederalRegulations, CFR）是将发表在“联邦公报（Federal Register, FR）”的一般性和永久性法规集合成册的法规典籍。

CFR的法规涵盖各方面主题，其中第21篇“食品与药品”就是美国食品药品监督管理局（Food and DrugAdministration, FDA）管理食品和药品的主要法规依据。

所谓知己知彼，百战不殆。

做好国际药品注册，需要从其法规源头入手。

本文带大家了解并熟悉CFR，尤其是第21篇“食品与药品”的结构以及内容。

1. CFR的结构与分类CFR共50篇（title），代表联邦法规涉及的领域和调整对象，有些篇有分篇（subtitle）；按前后顺序排列分别是：总则、保留、总统、会计、行政人事、保留、农业、外国人与公民、动物与动物产品、能源、联邦选举、银行金融、商业信用与资助、航空与航天、商业与外贸、商业实践、商品与证券交易、电力，水力资源保护、关税、雇员利益、食品与药品、对外关系、公路、住宅与城市发展、印第安人、国内收入、烟，酒产品与军火、司法行政、劳动、矿产资源、财政金融、国家防御、航运与可航水域、教育、巴拿马运河、公园，森林和公共财产、专利，商标与版权、抚恤金，津贴和老兵救助、邮政服务、环境保护、公共合同与财产管理、公共卫生、公共土地、抢险救灾、公共福利、航运、电讯、联邦收购规则系统、交通、野生动物与渔业。

每篇分为若干章（chapter），通常以法规颁发机构的名称为标题，有的章还分为分章（subchapter）；每章包含特定的法规领域的若干部分（part），有的部分由于内容多，又分为分部（subpart）。

美国FDA 21CFR820条文

21CFR 820.25 人員 (1) 應使人員了解若未正確執行所分派的任務時可能會始醫療器材產生瑕疵。此項了解應屬於訓練之一部份。 (2) 應使執行確認及驗收之人員了解他們在工作上可能遇到的瑕疵及錯誤，此項了解應成為該等人員工作之一部份。
矯正預防措施
Corrective & Pre(1) 責任與權限。製造商應為管理、執行及評估品質相關工作的人員，建立適當的責任、授權、及相互關係，並應授予執行這些任務的人員必要的獨立性和權限。 (2) 資源。製造商應提供適當資源(包括分派合格人員)，以執行管理、評估及執行其他工作(包括內部品質稽核)，以符合本部分規定之要求。
21CFR 820.180 紀錄管制一般要求 (a) 保密。若製造商認為紀錄屬於機密文件時，應在紀錄上做記號，以幫助FDA確定該紀錄是否是本章第20部份有關公共資訊法規所規定的得公開資料。 (b) 紀錄保存期。本部份規定之紀錄保存期應相當於器材之設計及預期壽命，但不得少於兩年。(自製造商將產品上市銷售之日起算)。
21CFR 820.3 定義(Definitions) (1) 製程確效(Process validation)：指根據客觀證據確定特定製程可以產出符合規定規格之結果或產品。 (2) 設計確認(Design validation)：指根據客觀證據確定器材規格符合使用者需要及指定用途。 (aa) 查證(Verification)：指經由審核及提供客觀證據證明已滿足規定要求之過程。
必要時應採取矯正措施，包括對有缺點項目進行複檢。應將各次品質稽核或複檢結果製作成報告，並由負責受檢項目之管理階層審核報告。應紀錄品質稽核及複檢日期及結果。
21CFR 820.25 人員 (a) 一般規定。製造商應僱用具備必要教育、背景、訓練及經驗之人員，以確保正確執行本部分規定之所有要求。 (b) 訓練。製造商應建立確認訓練需求的程序，以確保所有人員都接受訓練，以正確執行所分派的任務。應將訓練製作成文件

FDA CFR21

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

fda21 cfr partii的要求

FDA21 CFR Part II是美国食品和药物管理局（FDA）颁布的关于电子记录和电子签名（ERES）要求的法规。

本文将对FDA21 CFR Part II 的要求进行详细解析，包括其背景、主要内容和应用范围，以及对相关行业的影响等方面进行分析和阐述。

一、背景1.1 发展历程FDA21 CFR Part II的制定可以追溯到1997年，当时FDA颁布了最初的电子记录和电子签名规则。

这一规则的目的是确保电子记录及其相关的电子签名在与传统的纸质记录及手写签名一样具有法律效力。

随着信息技术的发展和应用的深化，FDA对ERES的要求进行了多次修订和补充完善，最终形成了如今的FDA21 CFR Part II。

1.2 法规意义FDA21 CFR Part II在制药、医疗器械、食品生产等领域具有广泛的适用性和指导性。

它不仅是对电子记录和电子签名的具体要求，更是对企业质量管理和合规性的重要标准。

对于受FDA监管的企业来说，严格遵守FDA21 CFR Part II的要求是确保产品质量和合规性的基本保障。

二、主要内容2.1 电子记录要求FDA21 CFR Part II对电子记录的要求主要包括记录的创建、修改、传输、存储和检索等方面。

其中，最核心的要求之一是保证电子记录的完整性、可靠性和可追溯性。

企业需要建立符合法规要求的电子记录系统，确保记录的真实性和完整性，同时能够在需要时提供完整的记录检索和审查。

2.2 电子签名要求与电子记录一样，FDA21 CFR Part II对电子签名的要求同样严格和细致。

电子签名系统必须具备确保签名者身份的合法性和唯一性，以及签名行为的不可抵赖性。

还需要为电子签名系统建立有效的管理和控制机制，以确保签名的正确性和可靠性。

2.3 电子记录和电子签名系统验证为了确保电子记录和电子签名系统的有效性和稳定性，FDA21 CFR Part II要求企业对这些系统进行周期性的验证和评估。

(完整版)美国FDA《联邦规章典集》(CFR)第21篇目录中文版

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）。

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]。

联邦法规第21款 -回复

联邦法规第21款-回复什么是联邦法规第21款？联邦法规第21款是美国联邦政府制定的一项法规，旨在监管食品和药品的安全性、有效性和质量。

该法规由美国食品药品监督管理局（FDA）负责执行，对于涉及食品和药品的生产、销售和使用都具有重要的影响。

它包含了广泛的规定，涵盖了产品注册、标签要求、生产工艺、质量控制、药物剂量和广告宣传等多个方面。

默认情况下，食品和药品在美国的销售和使用是受到联邦法规第21款的约束的。

该法规要求食品和药品的生产商在销售产品之前必须进行注册，并需要在产品上标注相应的信息，包括成分、用途、用法和剂量等。

此外，该法规要求生产商使用合规的生产工艺，并建立质量控制体系，以确保产品的安全性和有效性。

食品和药品的广告宣传也受到联邦法规第21款的限制，禁止虚假宣传和对疾病的不实宣称。

联邦法规第21款的实施过程中有几个重要的步骤和要求。

首先，生产商必须进行产品注册，以便FDA可以进行监管和追溯。

注册要求生产商提供详细的产品信息，包括成分、制造工艺和质量控制措施等。

其次，生产商必须遵守相应的标签要求，必须在产品上标注清楚产品的成分、用途和用法等信息。

如果生产商在标签上进行虚假宣传或未提供必要的警示信息，将会受到法律制裁。

此外，生产商必须建立符合法规要求的质量控制体系，并进行必要的质量管理和检验。

联邦法规第21款还规定了一系列关于食品和药品生产的基本要求。

例如，食品和药品的成分必须符合法规中的规定，并且不能含有禁止使用的物质。

此外，生产商需要采取适当的生产工艺和卫生措施，以确保产品的安全性和卫生标准。

药品的剂量和用法也必须符合法规中的规定，以确保患者获得安全和有效的治疗。

对于违反联邦法规第21款的制造商，FDA有权采取一系列的法律行动，包括警告信、罚款、产品召回和法律起诉等。

此外，FDA还可以对违规企业进行临时禁止销售或制造产品的措施，以保障公众的健康和安全。

在某些严重的违规行为中，FDA还可以直接参与产品的调查和收缴。

联邦法规第21款 -回复

联邦法规第21款-回复美国联邦法规第21款：食品和药物管理局(FDA) 的监管职责与授权导言美国联邦法规第21款确立了食品和药物管理局（FDA）的监管职责与授权，旨在确保美国市场上的食品、药品、医疗器械和化妆品的安全、有效性和质量。

本文将通过一步一步回答的方式，详细介绍联邦法规第21款的内涵、实施范围、执法程序和相关影响。

第一步：法规内涵联邦法规第21款是美国联邦法典中授权和确立FDA的职责与权力的法规条款。

该法规规定了FDA的职责，如监管和监督食品、药品、医疗器械、生物制品和化妆品。

此外，它还确定了FDA的权力，如批准新药、控制食品添加剂、监管广告宣传和执行相关执法程序等。

第二步：实施范围联邦法规第21款的实施范围涵盖了美国市场上销售的食品、药品、医疗器械和化妆品。

食品包括包装食品、饮料、膳食补充剂、添加剂等。

药品则包括处方药和非处方药。

医疗器械包括医疗设备、医疗用品和体外诊断产品。

化妆品则包括任何应用于人类身体的产品，如香水、化妆品和个人护理产品。

第三步：执法程序在联邦法规第21款下，FDA有权执行多种执法程序以确保产品的安全和合规性。

这些程序包括但不限于以下几个方面：1. 批准与监管新药：FDA负责审查并批准新药的上市销售，确保其安全、有效性和质量。

此外，FDA还监督药品的生产、销售和标签宣传活动，确保符合法规要求。

2. 控制食品添加剂：FDA对食品添加剂的使用进行监管，确保其安全性和使用限制符合法规要求。

食品添加剂必须经过FDA的批准或被认定为“安全”后方可用于食品中。

3. 监管广告宣传：FDA控制和监管食品、药品、医疗器械和化妆品的广告宣传活动。

FDA要求广告宣传必须真实准确，不得误导消费者。

对于涉及产品的疗效、功效和安全性的宣传，必须经过FDA的审查和批准。

4. 执行执法程序：当FDA发现产品不符合法规要求或存在安全风险时，将采取措施执行执法程序。

这包括但不限于警告信、缴获产品、召回产品、罚款和刑事调查。

计算机化系统验证的法规要求要点

我们谈一谈计算机化系统验证的那些法规要求。

在法规上，主要与以下十一部有关：1.(US FDA) 21CFR Partll美国联邦法规21篇第11部分电子记录与电子签名2.(US FDA)工业指南11部分电子记录与电子签名-范围和应用3.(US FDA)联邦法规第21篇第210 211部分，成品药的现行生产质量管理规范4.(ISPE)良好自动化生产实践指南，遵从GxP计算机化系统监管的风险管理方法5.(ISPE)GAMP GPG良好实践指南，GAMP架构下的系列良好实践指南6.(EU)欧盟药事法规第4卷GMP，附录11《计算机化系统》7.(PIC/S)GMP指南，药用产品良好生产实践指南(TGA)GMP，药用产品良好生产实践指南8.(PIC/S)在“GxP”监管环境下的计算机化系统良好实践(检察官指南)9.(WHO)GMP 2003, Annex 4 (WHO TechnicalReport Series, No. 908)10.(CFDA) 2010年版GMP及征求意见稿《计算机化系统》11.(CFDA)GSP附录二附录三《药品经营企业计算机系统》当使用密码或其他方式来控制系统的登录；关键数据输入后，应当由他人独立进行复核。

用电子方法保存的批记录，应当采用磁带、缩微胶卷、纸质副本或其他方法进行备份，以确保记录的安全，且数据资料在保存期内便于查阅。

附录1第七十条采用自控和监测系统的，应当经过验证，保证符合关键工艺的要求。

实践指南生成与应用FDA21CFR Parti 1EU GMP Annex11 WHOGMPPIC/S GMP CFDA 《计算机化系统》征求意见稿我们讲一讲相关的详细条款，摘录其中主要最关键的部分，供大家参考:一、CFDA GMP 及附录:第一百六十三条使用电子数据处理系统的，只有经授权的人员方可输入或更改数据，更改和删除情况应当有记录；应自控操作代替人工操作电子记录签名代替手写记录签名PAT 应ISPE GAM PIC/S PIO FDA Part CFDA 药fii科学技术进步法规变更5二、CFDA GMP 征求意见稿《计算机化系统》O 第四条应使用科学的风险评估方法来决定计算机化系统验证的范围与程度。

美国FDA认证

FDA美国1.FDA介绍：美国食品和药品管理局（FDA）负责监管食品接触材料，此类材料必须经过检测，确保达到食品接触安全标准。

美国联邦法规（CFR）第21章对此类材料作出具体规定，并将此类材料视为“间接食品添加剂”。

2.美国食品和药品管理局（FDA）列出三类食品添加剂：类型说明1)直接食品添加剂直接加入食品中的成分2)二级直接食品添加剂在食品处理过程中加入食品的成分，例如，用离子树脂、溶解萃取处理食品3)间接食品添加剂可能作为包装或加工设备组成部分与食品接触的物质，但并非直接加入食品之中*备注：仅“间接食品添加剂＂与食品接触材料相关3.与食品接触材料FD A测试项目：美国联邦法规（CFR）作出要求的食品接触材料：21 CFR 第 174-190 节。

重要章节包括：·21 CFR 第 175 节间接食品添加剂：涂层的添加剂和成分·21 CFR 第 176 节间接食品添加剂：纸张和纸板成分·21 CFR 第 177 节间接食品添加剂：聚合物（塑料）No材料标准1.有机涂层, 金属和电镀制品FDA 21 CFR第 175.300.节2.纸制品FDA 21 CFR 第176.170节3.木材FDA 21 CFR 第178.38004.ABS FDA 21 CFR 第181.32 or 180.22节5.丙烯酸树脂（Acrylic）FDA 21 CFR 第177.1010节6.食品容器的密封圈，密封衬垫FDA 21 CFR 第177.1210节7.EV A FDA 21 CFR 第177.1350节8.三聚氰氨树脂(密胺)FDA 21 CFR 第177.1460节9.尼龙塑料FDA 2 1 CFR 第177.1500节10.PP FDA 21 CFR 第177.1520节11.PE,OP FDA 21 CFR 第177.1520节。

美国《联邦规章典集》（CFR）目录

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]。

21 cfr 610 一般生物制品标准

美国联邦法规21CFR610部分是一般生物制品的标准，以下是其主要内容：
1.一般要求：对于一般生物制品，必须满足所有适用的生物制品标准和要求，并且必
须通过美国食品和药品管理局（FDA）的审查和批准。

2.定义：一般生物制品是指用于预防、治疗、诊断人类疾病或用于改变人类生理状态
的活性物质，但不包括疫苗、血液制品、基因治疗产品和细胞治疗产品。

3.注册和列名：制造商必须向FDA注册其产品，并在FDA的生物制品目录中列名。

4.生产和质量控制：制造商必须遵循良好生产规范（GMP）并确保其产品的质量控制
符合所有适用的标准和要求。

5.标签和包装：制造商必须在其产品的标签和包装上提供所有必要的说明和警告，以
确保安全有效地使用产品。

6.记录和报告：制造商必须保留所有必要的生产和质量控制记录，并在发现不良事件
或质量问题时向FDA报告。

7.监督和检查：FDA将定期检查制造商的设施和记录，以确保其符合所有适用的标准
和要求。

请注意，以上只是一般生物制品标准的一部分，具体内容可能因不同版本的法规而有所不同。

如果您需要更详细的信息，请参考最新的21CFR610部分或咨询专业人士。

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New Search Help | More About 21CFR[Code of Federal Regulations][Title 21, Volume 7][Revised as of April 1, 2017][CITE: 21CFR601]TITLE 21--FOOD AND DRUGSCHAPTER I--FOOD AND DRUG ADMINISTRATIONDEPARTMENT OF HEALTH AND HUMAN SERVICESSUBCHAPTER F--BIOLOGICSPART 601 LICENSINGSubpart A--General ProvisionsSec. 601.2 Applications for biologics licenses; procedures for filing.(a) General. To obtain a biologics license under section 351 of the Public Health Service Act for any biological product, the manufacturer shall submit an application to the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research (see mailing addresses in 600.2(a) or (b) of this chapter), on forms prescribed for such purposes, and shall submit data derived from nonclinical laboratory and clinical studies which demonstrate that the manufactured product meets prescribed requirements of safety, purity, and potency; with respect to each nonclinical laboratory study, either a statement that the study was conducted in compliance with the requirements set forth in part 58 of this chapter, or, if the study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance; statements regarding each clinical investigation involving human subjects contained in the application, that it either was conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter; or was not subject to such requirements in accordance with 56.104 or 56.105, and was conducted in compliance with requirements for informed consent set forth in part 50 of this chapter. A full description of manufacturing methods; data establishing stability of the product through the dating period; sample(s) representative of theproduct for introduction or delivery for introduction into interstate commerce; summaries of results of tests performed on the lot(s) represented by the submitted sample(s); specimens of the labels, enclosures, and containers, and if applicable, any Medication Guide required under part 208 of this chapter proposed to be used for the product; and the address of each location involved in the manufacture of the biological product shall be listed in the biologics license application. The applicant shall also include a financialcertification or disclosure statement(s) or both for clinical investigators as required by part 54 of this chapter. An application for a biologics license shall not be considered as filed until all pertinent information and data have been received by the Food and Drug Administration. The applicant shall also include either a claim for categorical exclusion under 25.30 or 25.31 of this chapter or an environmental assessment under 25.40 of this chapter. The applicant, or the applicant's attorney, agent, or other authorized official shall sign the application. An application for any of the following specified categories of biological products subject to licensure shall be handled as set forth in paragraph (c) of this section:(1) Therapeutic DNA plasmid products;(2) Therapeutic synthetic peptide products of 40 or fewer amino acids;(3) Monoclonal antibody products for in vivo use; and(4) Therapeutic recombinant DNA-derived products.(b) [Reserved](c)(1) To obtain marketing approval for a biological product subject to licensure which is a therapeutic DNA plasmid product, therapeutic synthetic peptide product of 40 or fewer amino acids, monoclonal antibody product for in vivo use, or therapeutic recombinantDNA-derived product, an applicant shall submit a biologics license application in accordance with paragraph (a) of this section except that the following sections in parts 600 through 680 of this chapter shall not be applicable to such products: 600.10(b) and (c), 600.11, 600.12, 600.13, 610.53, and 610.62 of this chapter.(2) To the extent that the requirements in this paragraph (c) conflict with other requirements in this subchapter, this paragraph (c) shall supersede other requirements.(d) Approval of a biologics license application or issuance of a biologics license shall constitute a determination that the establishment(s) and the product meet applicable requirements to ensure the continued safety, purity, and potency of such products. Applicable requirements for the maintenance of establishments for the manufacture of a product subject to this section shall include but not be limited to the good manufacturing practice requirements set forth in parts 210, 211, 600, 606, and 820 of this chapter.(e) Any establishment and product license for a biological product issued under section 351 of the Public Health Service Act (42 U.S.C. 201 et seq. ) that has not been revoked or suspended as of December 20, 1999, shall constitute an approved biologics license application in effect under the same terms and conditions set forth in such product license and such portions of the establishment license relating to such product.(f) Withdrawal from sale of approved biological products.A holder of a biologics license application (BLA) must report to FDA, in accordance with the requirements of 207.61 and 207.65, the withdrawal from sale of an approved biological product. The information must be submitted to FDA within 30 working days of the biological product's withdrawal from sale. The following information must be submitted: The holder's name; product name; BLA number; the National Drug Code; and the date on which the product is expected to be no longer in commercial distribution. The reason for the withdrawal of the biological product is requested but not required to be submitted.[64 FR 56450, Oct. 20, 1999, as amended at 70 FR 14983, Mar. 24, 2005;80 FR 18092, Apr. 3, 2015; 80 FR 37974, July 2, 2015; 81 FR 60221, Aug. 31, 2016]Sec. 601.3 Complete response letter to the applicant.(a) Complete response letter. The Food and Drug Administration will send the biologics license applicant or supplement applicant a complete response letter if the agency determines that it will not approve the biologics license application or supplement in its present form. (1) Description of specific deficiencies. A complete response letterwill describe all of the deficiencies that the agency has identified in a biologics license application or supplement, except as stated in paragraph (a)(2) of this section.(2) Inadequate data. If FDA determines, after a biologics license application or supplement is filed, that the data submitted are inadequate to support approval, the agency might issue a complete response letter without first conducting required inspections, testing submitted product lots, and/or reviewing proposed product labeling.(3) Recommendation of actions for approval.When possible, a complete response letter will recommend actions that the applicant might take to place its biologics license application or supplement in condition for approval.(b) Applicant actions.After receiving a complete response letter, the biologics license applicant or supplement applicant must take either of the following actions:(1) Resubmission. Resubmit the application or supplement, addressing all deficiencies identified in the complete response letter.(2) Withdrawal.Withdraw the application or supplement. A decision to withdraw the application or supplement is without prejudice to a subsequent submission.(c) Failure to take action. (1) FDA may consider a biologics license applicant or supplement applicant's failure to either resubmit or withdraw the application or supplement within 1 year after issuance of a complete response letter to be a request by the applicant to withdraw the application or supplement, unless the applicant has requested an extension of time in which to resubmit the application or supplement. FDA will grant any reasonable request for such an extension. FDA may consider an applicant's failure to resubmit the application or supplement within the extended time period or request an additional extension to be a request by the applicant to withdraw the application.(2) If FDA considers an applicant's failure to take action in accordance with paragraph (c)(1) of this section to be a request to withdraw the application, the agency will notify the applicant in writing. The applicant will have 30 days from the date of the notification to explain why the application or supplement should not be withdrawn and to requestan extension of time in which to resubmit the application or supplement. FDA will grant any reasonable request for an extension. If the applicant does not respond to the notification within 30 days, the application or supplement will be deemed to be withdrawn.[73 FR 39611, July 10, 2008]Sec. 601.4 Issuance and denial of license.(a) A biologics license shall be issued upon a determination by the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research that the establishment(s) and the product meet the applicable requirements established in this chapter. A biologics license shall be valid until suspended or revoked.(b) If the Commissioner determines that the establishment or product does not meet the requirements established in this chapter, the biologics license application shall be denied and the applicant shall be informed of the grounds for, and of an opportunity for a hearing on, the decision. If the applicant so requests, the Commissioner shall issue a notice of opportunity for hearing on the matter pursuant to 12.21(b) of this chapter.[42 FR 4718, Jan. 25, 1977, as amended at 42 FR 15676, Mar. 22, 1977;42 FR 19142, Apr. 12, 1977; 64 FR 56450, Oct. 20, 1999; 70 FR 14983, Mar. 24, 2005]Sec. 601.5 Revocation of license.(a) A biologics license shall be revoked upon application of the manufacturer giving notice of intention to discontinue the manufacture of all products manufactured under such license or to discontinue the manufacture of a particular product for which a license is held and waiving an opportunity for a hearing on the matter.(b)(1) The Commissioner shall notify the licensed manufacturer of the intention to revoke the biologics license, setting forth the grounds for, and offering an opportunity for a hearing on the proposed revocation if the Commissioner finds any of the following:(i) Authorized Food and Drug Administration employees after reasonable efforts have been unable to gain access to an establishment or a location for the purpose of carrying out the inspection required under 600.21 of this chapter,(ii) Manufacturing of products or of a product has been discontinued to an extent that a meaningful inspection or evaluation cannot be made, (iii) The manufacturer has failed to report a change as required by 601.12 of this chapter,(iv) The establishment or any location thereof, or the product for which the license has been issued, fails to conform to the applicable standards established in the license and in this chapter designed to ensure the continued safety, purity, and potency of the manufactured product,(v) The establishment or the manufacturing methods have been so changed as to require a new showing that the establishment or product meets the requirements established in this chapter in order to protect the public health, or(vi) The licensed product is not safe and effective for all of its intended uses or is misbranded with respect to any such use.(2) Except as provided in 601.6 of this chapter, or in cases involving willfulness, the notification required in this paragraph shall provide a reasonable period for the licensed manufacturer to demonstrate or achieve compliance with the requirements of this chapter, before proceedings will be instituted for the revocation of the license. If compliance is not demonstrated or achieved and the licensed manufacturer does not waive the opportunity for a hearing, the Commissioner shall issue a notice of opportunity for hearing on the matter under 12.21(b) of this chapter.[64 FR 56451, Oct. 20, 1999]Sec. 601.6 Suspension of license.(a) Whenever the Commissioner has reasonable grounds to believe that any of the grounds for revocation of a license exist and that by reason thereof there is a danger to health, the Commissioner may notify the licensed manufacturer that the biologics license is suspended andrequire that the licensed manufacturer do the following:(1) Notify the selling agents and distributors to whom such product or products have been delivered of such suspension, and(2) Furnish to the Center for Biologics Evaluation and Research or the Center for Drug Evaluation and Research, complete records of such deliveries and notice of suspension.(b) Upon suspension of a license, the Commissioner shall either:(1) Proceed under the provisions of 601.5(b) of this chapter to revoke the license, or(2) If the licensed manufacturer agrees, hold revocation in abeyance pending resolution of the matters involved.[64 FR 56451, Oct. 20, 1999, as amended at 70 FR 14983, Mar. 24, 2005] Sec. 601.7 Procedure for hearings.(a) A notice of opportunity for hearing, notice of appearance and request for hearing, and grant or denial of hearing for a biological drug pursuant to this part, for which the exemption from the Federal Food, Drug, and Cosmetic Act in 310.4 of this chapter has been revoked, shall be subject to the provisions of 314.200 of this chapter except to the extent that the notice of opportunity for hearing on the matter issued pursuant to 12.21(b) of this chapter specifically provides otherwise.(b) Hearings pursuant to 601.4 through 601.6 shall be governed by part12 of this chapter.(c) When a license has been suspended pursuant to 601.6 and a hearing request has been granted, the hearing shall proceed on an expedited basis.[42 FR 4718, Jan. 25, 1977, as amended at 42 FR 15676, Mar. 22, 1977;42 FR 19143, Apr. 12, 1977]Sec. 601.8 Publication of revocation.The Commissioner, following revocation of a biologics license under 21 CFR 601.5(b), will publish a notice in the Federal Register witha statement of the specific grounds for the revocation.[74 FR 20585, May 5, 2009]Sec. 601.9 Licenses; reissuance.(a) Compliance with requirements. A biologics license, previously suspended or revoked, may be reissued or reinstated upon a showing of compliance with requirements and upon such inspection and examination as may be considered necessary by the Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research.(b) Exclusion of noncomplying location.A biologics license, excluding a location or locations that fail to comply with the requirements in this chapter, may be issued without further application and concurrently with the suspension or revocation of the license for noncompliance at the excluded location or locations.(c) Exclusion of noncomplying product(s). In the case of multiple products included under a single biologics license application, a biologics license may be issued, excluding the noncompliantproduct(s), without further application and concurrently with the suspension or revocation of the biologics license for a noncompliant product(s).[64 FR 56451, Oct. 20, 1999, as amended at 70 FR 14983, Mar. 24, 2005] Subpart B [Reserved]Subpart C--Biologics LicensingSec. 601.12 Changes to an approved application.(a) General.(1) As provided by this section, an applicant must inform the Food and Drug Administration (FDA) (see mailing addresses in 600.2 of this chapter) about each change in the product, production process, quality controls, equipment, facilities, responsible personnel, or labeling established in the approved license application(s).(2) Before distributing a product made using a change, an applicant must assess the effects of the change and demonstrate throughappropriate validation and/or other clinical and/or nonclinical laboratory studies the lack of adverse effect of the change on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product.(3) Notwithstanding the requirements of paragraphs (b), (c), and (f) of this section, an applicant must make a change provided for in those paragraphs in accordance with a regulation or guidance that provides for a less burdensome notification of the change (for example, by submission of a supplement that does not require approval prior to distribution of the product or in an annual report).(4) The applicant must promptly revise all promotional labeling and advertising to make it consistent with any labeling change implemented in accordance with paragraphs (f)(1) and (f)(2) of this section. (5) A supplement or annual report must include a list of all changes contained in the supplement or annual report. For supplements, this list must be provided in the cover letter.(b) Changes requiring supplement submission and approval prior to distribution of the product made using the change (major changes).(1) A supplement shall be submitted for any change in the product, production process, quality controls, equipment, facilities, or responsible personnel that has a substantial potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product.(2) These changes include, but are not limited to:(i) Except as provided in paragraphs (c) and (d) of this section, changes in the qualitative or quantitative formulation, including inactive ingredients, or in the specifications provided in the approved application;(ii) Changes requiring completion of an appropriate human study to demonstrate the equivalence of the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product;(iii) Changes in the virus or adventitious agent removal or inactivation method(s);(iv) Changes in the source material or cell line;(v) Establishment of a new master cell bank or seed; and(vi) Changes which may affect product sterility assurance, such as changes in product or component sterilization method(s), or an addition, deletion, or substitution of steps in an aseptic processing operation.(3) The applicant must obtain approval of the supplement from FDA prior to distribution of the product made using the change. Except for submissions under paragraph (e) of this section, the following shall be contained in the supplement:(i) A detailed description of the proposed change;(ii) The product(s) involved;(iii) The manufacturing site(s) or area(s) affected;(iv) A description of the methods used and studies performed to evaluate the effect of the change on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product;(v) The data derived from such studies;(vi) Relevant validation protocols and data; and(vii) A reference list of relevant standard operating procedures (SOP's).(4) An applicant may ask FDA to expedite its review of a supplement for public health reasons or if a delay in making the change described in it would impose an extraordinary hardship on the applicant. Such a supplement and its mailing cover should be plainly marked: "Prior Approval Supplement-Expedited Review Requested.(c) Changes requiring supplement submission at least 30 days prior to distribution of the product made using the change. (1) A supplement shall be submitted for any change in the product, production process, quality controls, equipment, facilities, or responsible personnel that has a moderate potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. The supplement shall be labeled "Supplement--Changes Being Effected in 30 Days" or, if applicable under paragraph (c)(5) of this section,"Supplement--Changes Being Effected."(2) These changes include, but are not limited to:(i) [Reserved](ii) An increase or decrease in production scale during finishing steps that involves different equipment; and(iii) Replacement of equipment with that of similar, but not identical, design and operating principle that does not affect the process methodology or process operating parameters.(iv) Relaxation of an acceptance criterion or deletion of a test to comply with an official compendium that is consistent with FDA statutory and regulatory requirements.(3) Pending approval of the supplement by FDA, and except as provided in paragraph (c)(5) of this section, distribution of the product made using the change may begin not less than 30 days after receipt of the supplement by FDA. The information listed in paragraph (b)(3)(i) through (b)(3)(vii) of this section shall be contained in the supplement.(4) If within 30 days following FDA's receipt of the supplement, FDA informs the applicant that either:(i) The change requires approval prior to distribution of the product in accordance with paragraph (b) of this section; or(ii) Any of the information required under paragraph (c)(3) of this section is missing; the applicant shall not distribute the product made using the change until FDA determines that compliance with this section is achieved.(5) In certain circumstances, FDA may determine that, based on experience with a particular type of change, the supplement for such change is usually complete and provides the proper information, and on particular assurances that the proposed change has been appropriately submitted, the product made using the change may be distributed immediately upon receipt of the supplement by FDA. These circumstances may include substantial similarity with a type of change regularly involving a "Supplement--Changes Being Effected" supplement or a situation in which the applicant presents evidence that the proposed change has been validated in accordance with an approved protocol for such change under paragraph (e) of this section.(6) If the agency disapproves the supplemental application, it may order the manufacturer to cease distribution of the products made withthe manufacturing change.(d) Changes to be described in an annual report (minor changes). (1) Changes in the product, production process, quality controls, equipment, facilities, or responsible personnel that have a minimal potential to have an adverse effect on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product shall be documented by the applicant in an annual report submitted each year within 60 days of the anniversary date of approval of the application. The Director, Center for Biologics Evaluation and Research or the Director, Center for Drug Evaluation and Research, may approve a written request for an alternative date to combine annual reports for multiple approved applications into a single annual report submission.(2) These changes include, but are not limited to:(i) Any change made to comply with a change to an official compendium, except a change described in paragraph (c)(2)(iv) of this section, that is consistent with FDA statutory and regulatory requirements.(ii) The deletion or reduction of an ingredient intended only to affect the color of the product, except that a change intended only to affect Blood Grouping Reagents requires supplement submission and approval prior to distribution of the product made using the change in accordance with the requirements set forth in paragraph (b) of this section; (iii) An extension of an expiration dating period based upon full shelf life data on production batches obtained from a protocol approved in the application;(iv) A change within the container closure system for a nonsterile product, based upon a showing of equivalency to the approved system under a protocol approved in the application or published in an official compendium;(v) A change in the size and/or shape of a container containing the same number of dosage units for a nonsterile solid dosage form product, without a change from one container closure system to another; (vi) The addition by embossing, debossing, or engraving of a code imprint to a solid dosage form biological product other than a modified release dosage form, or a minor change in an existing code imprint; and(vii) The addition or revision of an alternative analytical procedure that provides the same or increased assurance of the identity, strength, quality, purity, or potency of the material being tested as the analytical procedure described in the approved application, or deletion of an alternative analytical procedure.(3) The following information for each change shall be contained in the annual report:(i) A list of all products involved; and(ii) A full description of the manufacturing and controls changes including: the manufacturing site(s) or area(s) involved; the date the change was made; a cross-reference to relevant validation protocols and/or SOP's; and relevant data from studies and tests performed to evaluate the effect of the change on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product.(iii) A statement by the holder of the approved application or license that the effects of the change have been assessed.(4) The applicant shall submit the report to the FDA office responsible for reviewing the application. The report shall include all the information required under this paragraph for each change made during the annual reporting interval which ends on the anniversary date in the order in which they were implemented.(e) An applicant may submit one or more protocols describing the specific tests and validation studies and acceptable limits to be achieved to demonstrate the lack of adverse effect for specified types of manufacturing changes on the identity, strength, quality, purity, or potency of the product as they may relate to the safety or effectiveness of the product. Any such protocols, or change to a protocol, shall be submitted as a supplement requiring approval from FDA prior to distribution of the product which, if approved, may justify a reduced reporting category for the particular change because the use of the protocol for that type of change reduces the potential risk of an adverse effect.(f) Labeling changes.(1) Labeling changes requiring supplement submission--FDA approval must be obtained before distribution of the product with the labelingchange. Except as described in paragraphs (f)(2) and (f)(3) of this section, an applicant shall submit a supplement describing a proposed change in the package insert, package label, container label, or, if applicable, a Medication Guide required under part 208 of this chapter, and include the information necessary to support the proposed change. An applicant cannot use paragraph (f)(2) of this section to make any change to the information required in 201.57(a) of this chapter. An applicant may report the minor changes to the information specified in paragraph (f)(3)(i)(D) of this section in an annual report. The supplement shall clearly highlight the proposed change in the labeling. The applicant shall obtain approval from FDA prior to distribution of the product with the labeling change.(2) Labeling changes requiring supplement submission--product with a labeling change that may be distributed before FDA approval. (i) An applicant shall submit, at the time such change is made, a supplement for any change in the package insert, package label, or container label to reflect newly acquired information, except for changes to the package insert required in 201.57(a) of this chapter (which must be made under paragraph (f)(1) of this section), to accomplish any of the following:(A) To add or strengthen a contraindication, warning, precaution, or adverse reaction for which the evidence of a causal association satisfies the standard for inclusion in the labeling under 201.57(c) of this chapter;(B) To add or strengthen a statement about abuse, dependence, psychological effect, or overdosage;(C) To add or strengthen an instruction about dosage and administration that is intended to increase the safety of the use of the product; and (D) To delete false, misleading, or unsupported indications for use or claims for effectiveness.(E) Any labeling change normally requiring a supplement submission and approval prior to distribution of the product that FDA specifically requests be submitted under this provision.(ii) Pending approval of the supplement by FDA, the applicant may distribute a product with a package insert, package label, or container label bearing such change at the time the supplement is submitted. 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21 CFR Part 11 联邦法规21章第11款主要规定内容涉及电子记录和电子签名