Food and Drug Regulations

C.04.412 (1) During a plasmapheresis session, the fabricator shall take a sample of blood or plasma in a manner that does not contaminate the sample or the source plasma.

(2) When the sample is taken, the fabricator shall clearly and permanently label the sample container with the unique identifier assigned to the source plasma.

(3) The fabricator shall ensure that the person who labels the sample container is the same person who labels the container holding the source plasma under subsection C.04.416(2).