Click to edit Master title style,Click to edit Master text styles,Second level,Third level,Fourth level,Fifth level,*,1,USP-NF,美国药典,/,国家处方集,2,Outline,Introduction,简介,Major Sections,主要章节,R,evision,修订,Summary,小结,3,Introduction,USP Organization,Standards Development,The Revision Process,USP Mission,To improve the health of people around the world through public standards and related programs that help ensure the quality and safety of medicines and foods.,USP,组织,药典标准的制定,修订程序,USP,使命,通过提供公共标准及其它相关项目以确保优质安全的药品与食品，促进全人类的健康。
4,Lyman Spalding surveyed physicians nationwide between 1817 and 1819,Spalding and 10 fellow physicians met in the U.S.Capitol January 1-7,1820 and the groundwork was laid for establishing the first,Pharmacopeia of the United States of America,1817,年至,1819,年，医学博士,Lyman Spalding,对全国的内科医师进行了调查,1820,年,1,月,1-7,日，,Spalding,和,10,名内科医师在美国国会大厦会面，完成了第一部,美国药典,的基础工作,How did the U.S.Pharmacopeia begin,5,How did the U.S.Pharmacopeia begin,6,1820-USP Founded:,USP standards for 217 drugs,1848-Drug Import Act:,USP legislatively mandated,1906-Federal Pure Food&,Drugs Act:,USP,and,NF,standards recognized,1938-Federal Food,Drug&,Cosmetic Act:,USP,and,NF,standards enforceable,by FDA,1990-OBRA recognized USP-DI,for off-label uses,1994-DSHEA“official,compendium”conformity for dietary supplements(voluntary),1820,年,USP,成立：,为,217,种药物制订了,USP,标准,1848,年,进口药品法：,USP,获得法律授权,1906,年,联邦洁净食品和药品法：,美国药典,(USP),和,国家处方集,(NF),标准得到认可,1938,年,联邦食品、药品和化妆品法：,美国药典,和,国家处方集,标准由食品和药品管理局,(FDA),强制执行,1990,年,联邦综合预算调节法,(,OBRA),认可,美国药典,/,药品信息,，供用药参考用,1994,年,被食品补充剂健康和教育法,(DSHEA),认可为食品补充剂的“法定标准”（自愿执行）,USPs Legal Recognition,7,USP,：,独立的非盈利组织,从事药典标准的制定及修订,公共标准、规格、纯度、质量、包装和标签,全球唯一独立药典机构,客观、独立的组织,更高效的标准制定程序,不能使用政府,(FDA),机密数据，例如新药标准,USP:,Private Not-For-Profit Organization,Compendial Standards,development and revision,Public Standards,strength,purity,quality,packaging,labeling,The only non-governmental Pharmacopeia in the world,Objective,independent,organization,Faster process for standards development,No access to confidential government(FDA)data such as acceptance criteria,USPs Legal Recognition,8,USP is made up of over 1,000,volunteers,Over 400 members of the USP,Convention,Council of Experts-56 elected,experts who chair expert,committees representing,standards and information,Over 600 volunteers serve on,Expert Committees,Board of Trustees-11 elected,voting members,USP,由,1,000,多名志愿,专家组成,USP,委员会有,400,多名,会员,专家主任委员会,由,56,名当选的专家组成，他,们分别担任相应标准和,信息专家委员会的主席,专家委员会包括,600,多,名专家,理事会,由,11,名有投票,权的当选委员组成,USPs Volunteer Decision Makers,9,USP,:United States Pharmacopeia,NF,:National Formulary,Available formats:,Print,CD-ROM,Online,USP-NF Introduction,Published annually since 2002,USP,：,美国药典,(United States Pharmacopeia),NF,:,国家处方集,(,National Formulary),格式：,印行本,光盘,网络版,自,2002,年起每年一版,10,A compilation of standards and,information for pharmaceuticals,Standards for drug substances,drug products,excipients,dietary supplements,General test methods and,definitions,Information about relevant,topics,美国医药产品标准和信息汇编,原料药、制剂、辅料、食品补充剂的质量标准,一般测试方法和定义,相关主题的信息,USP-NF Introduction,11,The process is open.USP strives for,input from various stakeholders:,Comments on information found in,the,USP-NF,or,Pharmacopeial Forum,Annual Science Meeting,Regional Compendial Groups,Stakeholders Forums,Industry Forum,标准的制定程序是开放的。
USP,努力征求所有利益相关,人员的意见：,关于,美国药典,/,国家处方,集,或,药典论坛,信息的,意见,年度学术会议,区域性药典团体,利益关系人论坛,制药工业论坛,How USP Establishes Standards,12,Major Sections,Front Matter,General Notices,General Chapters,Reagents,Reference Tables,Dietary Supplements,NF Monographs,USP Monographs,Glossary,前言,凡例,通则,试剂,参考表,食品补充剂,国家处方集,(NF),各论,USP,各论,术语,By-laws,changes from previous USP,Definitions and assumptions,General test methods,information,Materials used in monographs,Description,solubility,etc.,Dietary Supplements standards,Excipients,Drug substance,product standards,Glossary references,细则，修订,定义和统计学假设,一般测试方法、信息,各论中使用的材料,溶解度等,质量标准,辅料质量标准,原料药、制剂质量标准,术语索引,13,Front Matter,Mission and Preface,Mission,History,Rules and Procedures,（,Appendices,）,People,Convention,Council of Experts,Admissions,Inclusions,omissions and changes,Commentary,Committees response to comments,received about proposal that is official in,this adition,Appendices,A:Articles of Incorporation,B:Constitution,C:Rules and procedures,D:Communications Policy,E:Document Disclosure Policy,F:Proceedings,etc.,使命和前言,使命、历史、规则和程序（附录）,人员,USP,委员会、专家主任委员会、合作者,修订说明,收载，删减和修改,注释,专家委员会对关于本版本中正式生效修订,提议意见的反馈,附录,A:,组织章程,B:,章程与细节,C:,规则与程序,D:,通讯政策,E:,文件公开政策,F:,文献汇编等等,14,General Notices,The,General Notices and Requirements,section(the,General Notices,)presents the basic assumptions,definitions,and default conditions for the interpretation and application of the,United States Pharmacopeia,(,USP,)and the National Formulary(NF).,Requirements stated in these General Notices apply to all articles recognized in the USP and NF(the“compendia”)and to all general chapters unless specifically stated otherwise.,凡例部分为,USP,和,NF,的,解释、应用提供基本假,设、定义，及默认的条,件。
除另有说明，凡例中的要求适用于,USP,和,NF,（或称,“,药典,”,）中的所有。