Food and Drug Regulations
C.04.416 (1) Sections C.01.004 and C.04.019 do not apply to source plasma.
(2) A fabricator shall clearly and permanently label the container used to hold source plasma with
(a) the unique identifier assigned to the source plasma in the container;
(b) the statement “Source Plasma” or “Plasma destiné au fractionnement”;
(c) the statement “Caution: For Manufacturing Use Only” or “Précaution : À utiliser uniquement pour la fabrication”;
(d) the quantity of the source plasma;
(e) the name and quantity of the anticoagulant solution used during the plasmapheresis;
(f) the expiry date of the source plasma, expressed in an unambiguous format;
(g) subject to subsection C.04.413(3), a statement indicating that the source plasma tests negative for the disease agents for HIV, hepatitis B and hepatitis C;
(h) if the source plasma was collected from a donor who has received specific immunization, a statement indicating the immunogen that was used;
(i) the name, address and establishment licence number of the fabricator; and
(j) a statement indicating that the source plasma must be stored at a temperature of -20°C or colder.
(3) The unique identifier shall be placed on the container at the time of collection.
- SOR/78-545, s. 1
- SOR/85-1022, s. 7
- SOR/2006-353, s. 1
- Date modified: