Food and Drug Regulations

C.04.426 (1) The labelling provisions of sections C.01.004 and C.04.019 do not apply to human plasma or pilot samples thereof.

(2) In addition to complying with section C.04.414, each container of human plasma, other than a container of a pilot sample, shall be labelled with the following information:

• (a) the proper name of the product;

• (b) the name, address and establishment licence number of the distributor referred to in paragraph C.01A.003(b);

• (c) the donor number or symbol;

• (d) the collection date of the plasma;

• (e) [Repealed, SOR/85-1022, s. 11]

• (f) the statement: “Store at -20°C or colder” or the appropriate storage temperature where the plasma is intended for the manufacture of reagents;

• (g) a statement as to whether the plasma was collected from normal donors or from donors specifically immunized;

• (h) the immunizing antigen, if applicable;

• (i) the total volume or weight of plasma;

• (j) the total quantity and type of anticoagulant used in the plasmapheresis procedure; and

• (k) the test for hepatitis B antigen used and the results thereof.

(3) The label of each container used for human plasma that is collected pursuant to section C.04.419 shall bear conspicuous statements that the product may transmit viral hepatitis and that it is to be used for manufacturing purposes only.