首页 > FDA标准 > CPG Sec. 665.300 Usethe Names

FDA CPG Sec. 665.300 Use of Type A Medicated Article Proprietary Names in the Names of Medicated Feeds

蒋千琴 1/14/2022 浏览 219 FDA 美国

标准简介

CPG Sec. 665.300 Use of Type A Medicated Article Proprietary Names in the Names of Medicated Feeds[附网盘链接]是Food&Drug Administration于之前发布的FDA标准，适用于美国。

标准截图

CPG Sec. 665.300 Use of Type A Medicated Article Proprietary Names in the Names of Medicated Feeds[附网盘链接]
CPG Sec. 665.300 Use of Type A Medicated Article Proprietary Names in the Names of Medicated Feeds[附网盘链接](截图)

 

标准文档说明

标准文档类型为CPG Sec. 665.300 Use of Type A Medicated Article Proprietary Names in the Names of Medicated Feeds[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

Sec. 665.300 Use of Type A Medicated Article Proprietary Names in the Names of Medicated Feeds Compliance Policy Guide Guidance for FDA Staff This compliance policy guide represents the current thinking of the Food and Drug Administration (FDA) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA office responsible for this compliance policy guide as listed on the title page. I. Introduction The purpose of this compliance policy guide (CPG) is to provide guidance for FDA staff on the inclusion of proprietary names (i.e., brand or trade name) of Type A medicated articles in the names of medicated feeds. In general, FDA’s guidance documents, including this CPG, do not establish legally enforceable responsibilities. Instead, they describe the Agency’s current thinking on various topics and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required. II. Background In this CPG, the term proprietary name refers to the trademark or brand name of a drug product. The proprietary name is the exclusive name of a drug product owned by a company under trademark law regardless of registration status with the United States Patent and Trademark Office. To identify the source of the new animal drug used in a medicated feed, a medicated feed manufacturer may choose to include the proprietary name of the Type A medicated article in the name of the medicated feed manufactured from the Type A medicated article. III. Policy When the Type A medicated article proprietary name is included in the name of the medicated feed, the medicated feed labeling should include the name of the active ingredient(s), i.e., drug product. The proprietary name may only be used in the product name in a manner which is not misleading in any particular. To minimize the potential for confusion, the numerical part of the proprietary name, if any, should not be included in the

网盘链接

百度网盘：https://pan.baidu.com/s/1uOt5MsfXaY3FHbiRzx3CCw
提取码：qw23

【温馨提示】大资料ISO是提供信息发布的专业信息类网站，所有内容均由用户发布，不代表本站观点，本站亦不存储所涉及的文件及资料。如有【免费资料】以及【付费资料】,请用户根据自己的需求，自行判断是否需要获取。如有交易诈骗、内容侵权可发送邮件至kf@dzl100.com，我们审查后若发现情况属实，会立即对相关内容进行删除处理。

加载用时：57.9446 毫秒

相关评论

相关文章