The container label of blood or blood components intended for transfusion must bear encoded information in a format that is machine-readable and approved for use by the Director, CBER.
Who is subject to this machine-readable requirement? All blood establishments that manufacture, process, repack, or relabel blood or blood components intended for transfusion and regulated under the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act.
What blood products are subject to this machine-readable requirement? All blood and blood components intended for transfusion are subject to the machine-readable information label requirement in this section.
What information must be machine-readable? Each label must have machine-readable information that contains, at a minimum:
- A unique facility identifier
- Lot number relating to the donor
- Product code
- ABO and Rh of the donor (exceptions to this requirement are described in paragraphs (c)(9) and (i)(5) of section 606.121).
How must the machine-readable information appear? The machine-readable information must:
- Be unique to the blood or blood component;
- Be surrounded by sufficient blank space so that the machine-readable information can be scanned correctly; and
- Remain intact under normal conditions of use.
Where does the machine-readable information go? The machine-readable information must appear on the label of any blood or blood component which is or can be transfused to a patient or from which the blood or blood component can be taken and transfused to a patient.