美国药典简介

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  除另有规定外,USP38–NF 33文本的实施时间是2015年5月1日,在USP 38–NF 33第一补充文本实施时间是2015年8月1日,和USP 38–NF 33第二补充文本实施时间是2015年12月1日。

历史

  1820年1月1日,11位医生在美国国会大厦的参议院聚会,商讨创作USP。他们意图编出一部最佳治疗药品的汇编,给出适用的药名,并提供制剂的处方。经过不到一年的时间,USP第一版于1820年12月15日出版。它的前言提出,刊印药典的目的是从具有治疗效力的物质中,选择那些功能充分证实、作用明确了解的药物,并由此做出制剂,使其效力得到最大的发挥。它也要给采用的各种药物提出一个合适而确切的名称,以防止医师与药师间交流的麻烦与不确定性。这一要求在今天的药典中仍然如此。

随着时间的推移,USP的性质从处方汇编改变为药品标准的汇编。它的出版周期也改变了,从1840年到1942年,每10年一版;1942到2000年,每5年一版;从2002年开始每年一版。

  1888年,美国药学会出版了第一部国家处方集,名称叫非法定制剂的国家处方集,简称NF。USP和NF是被1906年美国食品药品法和1938年的食品药品和化妆品法所认可的。1975年USP与NF合并出版,叫USP-NF。

现在,USP根据分析和计量科学以及其他相关学科的进展,继续发展USP-NF成为提供药品标准的汇编。

USP–NF的内容

  收载了药物、生物制品、食品增补剂和赋形剂的科学标准,可用于生产各种剂型和成品。USP30-NF25各论中所提供的所有物品(除极少数外)在美国都是法定上市的或者含在法定上市的物品中。

  在USP-NP的各论中,一个物质(原料)或制品(制剂)列有该物品的定义、包装、储存、其他项以及技术要求。技术要求包括一系列的常用试验(性状、鉴别、杂质、含量测定)和特殊试验,每项试验用一种或多种分析方法及其判定标准。组分是指药物或赋形剂。赋形剂是指有意加入到剂型的组方中,除了活性物质以外的任何成分,但它不一定是无活力的。药物和赋形剂可以是合成的、半合成的、来自自然界的或用重组技术生产的。需要效价测定的大分子和混合物通常叫做生物制品或生物技术物品。

  USP–NF不断修订。USP-NF每年进行修订并以一年两次增补本的形式发布,USP网站也在加速修订:勘误表,临时修订公告(IRAs),修订快报。

USP管理,标准制定和咨询机构

  USP的管理,标准制定和咨询机构,包括USP代表大会、董事会、专家理事会及其专家委员会,专家顾问小组(以前称咨询小组)和工作人员。其他的志愿者机构包括利益相关论坛、项目团队和咨询团体,以其咨询的能力为USP的管理,标准制定和管理机构作出贡献。

其他USP出版物

  《色谱柱》、《USP 词典》、《USP药剂师药典》、《USP膳食补充剂标准汇编》、《美国食品化学品法典》



About USP

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USP–NF is published in continuing pursuit of the mission of USP: To improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods.

This section provides background information on the United States Pharmacopeial Convention (USP), as well as general information about the 38th revision of the United States Pharmacopeia (USP 38) and the 33rd edition of the National Formulary (NF 33) and their Supplements. Unless otherwise noted, the text in USP 38–NF 33 is official May 1, 2015, the text in the First Supplement to USP 38–NF 33 is official August 1, 2015, and the text in the Second Supplement to USP 38–NF 33 is official December 1, 2015.

On January 1, 1820, 11 physicians met in the Senate Chamber of the U.S. Capitol building to establish a pharmacopeia for the United States. These practitioners sought to create a compendium of the best and most fully established medicines, give them useful names, and provide recipes for their preparation. Nearly one year later, on December 15, 1820, the first edition of The Pharmacopoeia of the United States was published. Over time, the nature of the United States Pharmacopeia (USP) changed from being a compendium of recipes to a compendium of documentary standards for identity and quality that typically involve reference materials used as comparison standards in specified tests and assays. The publishing schedule of USP also changed over time. From 1820 to 1942, USP was published at 10-year intervals; from 1942 to 2000, at five-year intervals; and beginning in 2002, annually.

In 1888 the American Pharmaceutical Association published the first National Formulary under the title The National Formulary of Unofficinal [sic] Preparations (NF). Both USP and NF were recognized in the Federal Food and Drugs Act of 1906 and again in the Federal Food, Drug, and Cosmetic Act of 1938 (FD&C Act). In 1975, USP acquired the National Formulary (NF), which now contains excipient standards that also call for reference materials. USP continues to develop USP and NF, through the work of the Council of Experts, into compendia that provide standards for articles based on advances in analytical and metrological science. As these and allied sciences evolve, so do USP and NF.

USP–NF contains official substance (ingredient) and product monographs for official articles recognized in USP–NF. The terms official substance, official preparation, and official article are defined in the General Notices and Requirements (General Notices). With few exceptions, all articles for which monographs are provided in USP–NF are legally marketed in the United States or are contained in legally marketed articles. USP–NF also includes monographs for compounded preparations.

A USP–NF monograph for an official substance, product, or preparation may consist of various components, including the article's name; definition; packaging, storage, and other requirements; and a specification. The specification consists of a series of universal tests (description, identity/identification, impurities, assay) and specific tests, one or more analytical procedures for each test, and acceptance criteria. Ingredients are defined as either drug substances or excipients. An excipient is any component, other than the active substance(s), intentionally added to the formulation of a dosage form. Excipients are not necessarily inert. Drug substances and excipients may be synthetic, semi-synthetic, drawn from nature (natural source), or manufactured using recombinant technology. Drugs that consist of larger molecules and mixtures requiring a potency test are usually referred to as biologicals or biotechnological articles.

General chapters provide frequently cited procedures, sometimes with acceptance criteria, in order to compile into one location repetitive information that is applicable to many monographs. New and revised monographs and general chapters and omitted monographs from this edition are indicated in the Admissions section.

USP's governing, standards-setting, and advisory bodies include the USP Convention, the Board of Trustees, the Council of Experts and its Expert Committees, Expert Panels, and staff. Additional volunteer bodies include Stakeholder Forums, Project Teams, and Advisory Groups, which act in an advisory capacity to provide input to USP's governing, standards-setting, and management bodies.




Description link:http://www.usp.org/about-usp