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LEGAL RECOGNITION 法律认可

所属教程:医学英语阅读写作

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2018年10月13日

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LEGAL RECOGNITION 法律认可

Recognition of USP–NF— USP–NF is recognized by law and custom in many countries throughout the world. In the United States, the federal Food, Drug, and Cosmetic Act (FD&C Act) defines the term “official compendium” as the official USP, the official NF, the official Homeopathic Pharmacopeia of the United States, or any supplement to them. FDA may enforce compliance with official standards in USP–NF under the adulteration and misbranding provisions of the FD&C Act. These provisions extend broad authority to FDA to prevent entry to or remove designated products from the United States market on the basis of standards in the USP–NF. 《美国药典/国家处方集》在世界各地都得到法律和传统的认可。在美国,联邦《食品药品化妆品法案》(FD&CAct)中明确的“官方手册”就是指官方的《美国药典》、官方的《国家处方集》、官方的《美国顺势疗法药典》或者它们的《增补本》。FDA在《食品药品化妆品法案》的掺假和标示不符条文下可能会按照《美国药典/国家处方集》的官方标准强制执行。这些条文扩展了FDA的权威,它们可以依据《美国药典/国家处方集》的标准禁止某些指定产品流人或流出美国市场。

The identity of an official article, as expressed by its name, is established if it conforms in all respects to the requirements of its monograph and other relevant portions of the compendia. The FD&C Act stipulates that an article may differ in strength, quality, or purity and still have the same name if the difference is stated on the article's label. FDA requires that names for articles that are not official must be clearly distinguishing and differentiating from any name recognized in an official compendium. Official preparations (a drug product, a dietary supplement including nutritional supplements, or a finished device) may contain additional suitable ingredients. 只要与各论中的要求和手册中其他相关部分相符,一个法定品种的统一性就可以确立,正如它名称所表达的。《食品药品及化妆品法案》规定品种在规格、质量或者纯度方面可以有不同,而且只要在品种标签上注明可以用同样的名称。FDA要求非法定的品种名称必须和法定手册中认可的名称明确区分、区别开来。法定制剂(药成品、食品补充剂包括营养添加剂或者成品装置)可以包含附加的合适的制剂成分。

Drugs — USP's goal is to have substance and preparation (product) monographs in USP–NF for all FDA-approved drugs, including biologics, and their ingredients. USP also develops monographs for therapeutic products not approved by FDA, e.g., pre-1938 drugs, dietary supplements, and compounded preparations. Although submission of information needed to develop a monograph by the Council of Experts is voluntary, compliance with a USP–NF monograph, if available, is mandatory. 药品美国药典的目标就是让《美国药典/国家处方集》中药物和制剂(成品)各论涵盖所有FDA核准的药品,包括生物药品以及它们的成分。美国药典也开发不被FDA核准的治疗产品的各论,如1938年前的药品、食品补充剂和复合制剂。尽管专家委员会提交开发各论所需要的信息是自愿的,但是如能够提供的话,则必须符合《美国药典国家处方集》各论。

Biologics — In the United States, although some biologics are regulated under the provisions of the Public Health Service Act (PHSA), provisions of the FD&C Act also apply to these products. For this reason, products approved under the PHSA should comply with the adulteration and misbranding provisions of the FD&C Act at Section 501(b) and 502(g) and, thus, should conform to applicable official monographs in USP–NF. 生物制品在美国,尽管某些生物制品在《公共卫生服务法案》(PHSA)条文中受到管制,联邦《食品药品化妆品法案》条文也适用了这些产品。正因如此,《公共卫生服务法案》下核准的产品必须服从《食品药品化妆品法案》501项(b)条和502项(g)条下的掺假和标示不符条文,因此必须遵守《美国药典/国家处方集》中适用的官方各论。

Medical Devices — Section 201(h) of the FD&C Act defines a device as an instrument, apparatus, similar article, or component thereof recognized in USP–NF. There is no comparable recognition of USP's standards-setting authority and ability to define a medical device as exists for other FDA-regulated therapeutic products. 医疗器械《食品药品化妆品法案》第201项(h)条把装置定义为设备、仪器.、类似的品种或者在《美国药典/国家处方集》中认可的组件。美国药典委员会还没有被认可类似的标准制定权威和能力来定义现存的由FDA控制的治疗产品的其他医疗设备。

Dietary Supplements — The Dietary Supplement Health and Education Act of 1994 amendments to the FD&C Act name USP—NF as the official compendia for dietary supplements. The dietary supplement must be represented as conforming to a USP–NF dietary supplement monograph. 膳食补充剂对《食品药品及化妆品法案》修订的《1994膳食补充剂卫生和教育法案》把《美国药典/国家处方集》提名为膳食补充剂的官方手册^膳食补充剂必须与《美国药典/国家处方集》膳食补充剂各论相符。

Compounded Preparations — Preparation monographs provide information or standards applicable in compounding. Standards in USP–NF for compounded preparations may be enforced at both the state and federal levels, e.g., if a practitioner writes a prescription for a compounded preparation that is named in a USP–NF monograph, the preparation, when tested, must conform to the stipulations of the monograph so named. 复合制剂制剂各论提供适合调配的信息和标准。《美国药典/国家处方集》复合制剂的标准可以在州和联邦两个级别实施,比如:如果医师开复合制剂的处方,其名称在《美国药典/国家处方集》的各论中,在检查时该制剂必须遵照该名称下的各论规定。

医学英语


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