LEGAL RECOGNITION 法律認可

LEGAL RECOGNITION 法律認可

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. 《美國藥典/國家處方集》在世界各地都得到法律和傳統(tǒng)的認可。在美國，聯(lián)邦《食品藥品化妝品法案》(FD&CAct)中明確的“官方手冊”就是指官方的《美國藥典》、官方的《國家處方集》、官方的《美國順勢療法藥典》或者它們的《增補本》。FDA在《食品藥品化妝品法案》的摻假和標示不符條文下可能會按照《美國藥典/國家處方集》的官方標準強制執(zhí)行。這些條文擴展了FDA的權威，它們可以依據(jù)《美國藥典/國家處方集》的標準禁止某些指定產(chǎn)品流人或流出美國市場。

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. 只要與各論中的要求和手冊中其他相關部分相符，一個法定品種的統(tǒng)一性就可以確立，正如它名稱所表達的?！妒称匪幤芳盎瘖y品法案》規(guī)定品種在規(guī)格、質量或者純度方面可以有不同，而且只要在品種標簽上注明可以用同樣的名稱。FDA要求非法定的品種名稱必須和法定手冊中認可的名稱明確區(qū)分、區(qū)別開來。法定制劑(藥成品、食品補充劑包括營養(yǎng)添加劑或者成品裝置)可以包含附加的合適的制劑成分。

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. 藥品美國藥典的目標就是讓《美國藥典/國家處方集》中藥物和制劑(成品)各論涵蓋所有FDA核準的藥品，包括生物藥品以及它們的成分。美國藥典也開發(fā)不被FDA核準的治療產(chǎn)品的各論，如1938年前的藥品、食品補充劑和復合制劑。盡管專家委員會提交開發(fā)各論所需要的信息是自愿的，但是如能夠提供的話，則必須符合《美國藥典國家處方集》各論。

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. 生物制品在美國，盡管某些生物制品在《公共衛(wèi)生服務法案》(PHSA)條文中受到管制，聯(lián)邦《食品藥品化妝品法案》條文也適用了這些產(chǎn)品。正因如此，《公共衛(wèi)生服務法案》下核準的產(chǎn)品必須服從《食品藥品化妝品法案》501項(b)條和502項(g)條下的摻假和標示不符條文，因此必須遵守《美國藥典/國家處方集》中適用的官方各論。

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. 醫(yī)療器械《食品藥品化妝品法案》第201項(h)條把裝置定義為設備、儀器.、類似的品種或者在《美國藥典/國家處方集》中認可的組件。美國藥典委員會還沒有被認可類似的標準制定權威和能力來定義現(xiàn)存的由FDA控制的治療產(chǎn)品的其他醫(yī)療設備。

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. 膳食補充劑對《食品藥品及化妝品法案》修訂的《1994膳食補充劑衛(wèi)生和教育法案》把《美國藥典/國家處方集》提名為膳食補充劑的官方手冊^膳食補充劑必須與《美國藥典/國家處方集》膳食補充劑各論相符。

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. 復合制劑制劑各論提供適合調配的信息和標準?！睹绹幍?國家處方集》復合制劑的標準可以在州和聯(lián)邦兩個級別實施，比如:如果醫(yī)師開復合制劑的處方，其名稱在《美國藥典/國家處方集》的各論中，在檢查時該制劑必須遵照該名稱下的各論規(guī)定。

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