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.