The minimum count for plateletpheresis must be above [ Select ] ["150,000/ uL", "200,000/ uL", "250,000/ uL"] . The interval between plateletpheresis donations is at least [ Select ] ["3", "5", "4", "2"] days, not to exceed more than [ Select ] ["twice a week", "once a week"] , or more than [ Select ] ["24", "12", "52", "48"] times per year. Under the auspices of the FDA, blood is regarded both as a biologic and a [ Select ] ["drug", "treatment", "medical device"] . The regulations for donor screening are outlined in the [ Select ] ["CFR", "CMS", "CDC", "CBER"] , Title 21, parts 211, [ Select ] ["500-699", "850-999", "600-799"] . drug; CFR; 600-799; The U.S. Food and Drug Administration (FDA) is a regulating agency. Its regulations for donor screening are outlined in the Code of Federal Regulations (CFR), Title 21, parts 211, 600-799. Under the auspices of the FDA, blood is regarded both as a biologic and a drug.
In 1988, the Center for Biologics Evaluation and Research (CBER) was formed. CBER is responsible for regulating the collection of blood and blood components used for transfusion and for the manufacture of pharmaceuticals derived from blood and blood components. CBER develops and enforces quality standards, inspects blood establishments, and monitors reports of errors, accidents, and adverse clinical events. Modern Blood Banking and Transfusion Practices, 7th Ed. Chapter 13, page 282.