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§ 71.37 研究用着色剂的豁?Exemption of color additives for investigational use)

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放大字体缩小字体2011-09-01 04:32:09 来源:GPO 浏览次数9span id="hits">2706
核心提示:一种研究用着色剂或食品、药品、化妆品中含有专家认为安全的研究用着色剂的运输应享有豁免法案402(c)?01(a)或?01(e)部分的权利,进行该运输的人员应持有足够的记录,根据部门相应被授权人员的要求,在适当时机,进行记录检查和备份、/div>
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备注 一种研究用着色剂或食品、药品、化妆品中含有专家认为安全的研究用着色剂的运输应享有豁免法案402(c)?01(a)或?01(e)部分的权利,进行该运输的人员应持有足够的记录,根据部门相应被授权人员的要求,在适当时机,进行记录检查和备份、/td>

更多关于着色剂使用申请的法规,请详?a target="_blank" href="//www.sqrdapp.com/law/dongtai/173325.html">美国FDA 21 CFR ?1部分关于着色剂使用申请的法规汇怺/font>、br />
   71.37 Exemption of color additives for investigational use.

  (a A shipment or other delivery of a color additive or of a food, drug, or cosmetic containing such a color additive for investigational use by experts qualified to determine safety shall be exempt from the requirements of section 402(c? 501(a? or 601(e of the act, provided that the color additive or the food, drug, or cosmetic containing the color additive bears a label which states prominently, CautionContains new color additiveFor investigational use only. No animals used in such investigations, or their products, such as milk or eggs, shall be used for food purposes, unless the sponsor or the investigator has submitted to the Commissioner data demonstrating that such use will be consistent with the public health, and the Commissioner, proceeding as he would in a matter involving section 409(i of the act, has notified the sponsor or investigator that the proposed disposition for food is authorized. Any person who contests a refusal to grant such authorization shall have an opportunity for a regulatory hearing before the Food and Drug Administration pursuant to part 16 of this chapter.

  (b The person who introduced such shipment or who delivers the color additive or a food, drug, or cosmetic containing such an additive into interstate commerce shall maintain adequate records showing the name and post-office address of the expert to whom the color additive is shipped, date, quantity, and batch or code mark of each shipment and delivery for a period of 2 years after such shipment and delivery. Upon the request of a properly authorized employee of the Department, at reasonable times, he shall make such records available for inspection and copying.

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