FDA CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor
标准简介
CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor[附网盘链接]是Food&Drug Administration发布的FDA标准，适用于U.S。标准截图
![CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor[附网盘链接]](/img/20210914103651y4eqy.jpg)
标准文档说明
标准文档类型为CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor[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
Compliance Policy Guide CPG Sec. 230.150: Blood Donor Classification Statement, Paid or Volunteer Donor Guidance for FDA Staff This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) 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 staff responsible for this guidance as listed on the title page. I. INTRODUCTION: The purpose of this Compliance Policy Guide is to provide guidance to FDA staff on the labeling of blood and blood components intended for transfusion with the appropriate donor classification statement (i.e., “paid donor” or “volunteer donor”). FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations unless specific regulatory or statutory requirements are cited. The use of the word “should” in FDA’s guidances means that something is suggested or recommended but not required. II. BACKGROUND: In a Federal Register notice dated January 13, 1978 (43 FR 2142), the Agency issued a final rule which required that blood and blood components intended for transfusion include a donor classification statement on the container label to indicate collection from a “paid donor” or “volunteer donor.” This labeling requirement appears at Title 21 of the Code of Federal Regulations (CFR) 21 CFR 606.121(c)(8)(v). The regulation defines a “paid donor” as a person who receives monetary payment for a blood donation (21 CFR 606.121(c)(8)(v)(A)). A “volunteer donor” is a person who does not receive monetary payment for a blood donation (21 CFR 606.121(c)(8)(v)(B)). The regulation also states that benefits such as time off from work, membership in blood assurance programs, and cancellation of non-replacement fees that are not readily convertible to cash, do not constitute monetary payment. (21 CFR 606.121(c)(8)(v)(C)). 1
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