Suppr超能文献

请求豁免膳食成分100%同一性检测的请愿书:膳食补充剂生产、包装、标签标注或储存操作的现行良好生产规范。暂行最终规则。

Petition to request an exemption from 100 percent identity testing of dietary ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. Interim final rule.

出版信息

Fed Regist. 2007 Jun 25;72(121):34959-69.

Abstract

The Food and Drug Administration (FDA) is issuing an interim final rule (IFR) that sets forth a procedure for requesting an exemption from the requirement in the final rule "Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements," published elsewhere in this issue of the Federal Register, that the manufacturer conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient. This IFR allows for submission to, and review by, FDA of an alternative to the required 100 percent identity testing of components that are dietary ingredients, provided certain conditions are met and establishes a requirement for retention of records relating to the FDA's response to an exemption request.

摘要

美国食品药品监督管理局(FDA)正在发布一项暂行最终规则(IFR),该规则规定了一种程序,用于请求豁免本期《联邦公报》其他地方发布的最终规则“膳食补充剂生产、包装、标签或储存操作中的现行良好生产规范”中要求制造商至少进行一项适当测试或检查以核实任何作为膳食成分的成分身份的规定。本暂行最终规则允许在满足某些条件的情况下,向FDA提交并由其审查替代对作为膳食成分的成分进行所需的100%身份测试的方法,并规定了保留与FDA对豁免请求的回应相关记录的要求。

文献检索

告别复杂PubMed语法,用中文像聊天一样搜索,搜遍4000万医学文献。AI智能推荐,让科研检索更轻松。

立即免费搜索

文件翻译

保留排版,准确专业,支持PDF/Word/PPT等文件格式,支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述,25分钟生成高质量综述,智能提取关键信息,辅助科研写作。

立即免费体验