Code of Federal Regulations (CFR)

The CFR is a gargantuan encyclopedia, 50 titles in length, with United States government regulations on everything from energy and the postal service all the way to domestic security and national defense. In the blood bank, we are most concerned with the 21st title (21 CFR), “Food and Drugs.” This title gives the FDA authority over U.S. blood banks, and defines numerous requirements for blood banks.

Several parts of 21 CFR are most applicable to blood establishments, including:

• 21 CFR 210 (Current Good Manufacturing Practices for drugs in general)
• 21 CFR 211 (More cGMPs)
• 21 CFR 600, 601, 606, 630, and 640 (blood specific regulations)
• 21 CFR 820 (Quality Systems)

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