美国良好操作规范(GMP—21CFR Part 111).doc

[联邦法规] [Title 21, Volume 2] [标题21，第2卷] [Revised as of April 1, 2008] [日期为2008年4月1日] [CITE: 21CFR111] [引用：21CFR111] TITLE 21--FOOD AND DRUGS 标题21 -食品和药物 CHAPTER I--FOOD AND DRUG ADMINISTRATION 第一章-食品和药物管理局 DEPARTMENT OF HEALTH AND HUMAN SERVICES 部卫生与公众服务 SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION 子章节B组-人类食用的食物 PART 111 第111 CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS 现行良好操作规范在制造，包装，标签，或对食品补充剂控股作业 Subpart A--General Provisions 子部分-一般规定 Sec. 秒。 111.1 Who is subject to this part? 111.1谁是受这部分？ (a) Except as provided by paragraph (b) of this section, you are subject to this part if you manufacture, package, label, or hold a dietary supplement, including: （一）除提供段（二本节），你必须遵守 ， 如果你这部分的制造，包装，标签，或持有饮食的补充，其中包括： (1) A dietary supplement you manufacture but that is packaged or labeled by another person; and （1）膳食补充剂 ， 但你制造的包装物或由他人标记;及 (2) A dietary supplement imported or offered for import in any State or territory of the United States, the District of Columbia, or the Commonwealth of Puerto Rico. （2）膳食补充剂进口或在任何国家或美国境内的进口提供，哥伦比亚特区，或波多黎各联邦。 (b) The requirements pertaining to holding dietary supplements do not apply to you if you are holding those dietary supplements at a retail establishment for the sole purpose of direct retail sale to individual consumers. （二）的要求举行有关膳食补充剂并不适用于你是否保持在一个直接零售个人消费者零售的唯一目的建立的膳食补充剂。 A retail establishment does not include a warehouse or other storage facility for a retailer or a warehouse or other storage facility that sells directly to individual consumers. 阿零售的建立 ， 并不包括为零售商或仓库或其他存储设施 ， 销售直接向个人消费者仓库或其他存储设施。 Sec. 秒。 111.3 What definitions apply to this part? 111.3什么定义适用于本部分？ The definitions and interpretations of terms in section 201 of the Federal Food, Drug, and Cosmetic Act (the act) apply to such terms when used in this part. For the purpose of this part, the following definitions also apply: 的定义和节联邦食品，药品和化妆品法（该法）201条款的解释适用于本部分时 ， 使用的条款就本部分。为此，下列定义