Food and Drug Regulations

Version of section C.04.416 from 2006-12-14 to 2014-10-22:

  •  (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.
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