Code of Federal Regulations (CFR) Title 21
Part 210 applies to all drug manufacturers, including blood and blood components. Some regulations that are included in
Part 211 also apply to blood. There are more specific regulations for blood and blood components in
Part 600. Because these sections were created at different times, there is noticeable redundancy.
Not all activities in the transfusion service are regulated by the cGMP sections of the CFR. For example, billing and transporting specimens are not part of the cGMP regulations.
