Blood Regulations (SOR/2013-178)

Marginal note:Contents of label — blood for transfusion

• 64 (1) An establishment that collects blood for transfusion must ensure that all of the following information appears on the label of the blood:

  • (a) the establishment’s name and civic address;

  • (b) the establishment’s licence number, if it has one, or its registration number;

  • (c) the donation code;

  • (d) a statement of whether the donation is whole blood or a blood component, and if it is a component, its name;

  • (e) when appropriate, the ABO group and Rh factor of the blood;

  • (f) except in the case of apheresis, the approximate volume of the whole blood collected;

  • (g) the approximate volume of the contents of the container;

  • (h) the name of any anticoagulant or additive in the container;

  • (i) the recommended storage temperature;

  • (j) the expiry date and, if applicable, the time;

  • (k) in the case of blood for transfusion, a warning that the blood could transmit infectious agents; and

  • (l) in the case of allogeneic blood for transfusion, a direction to refer to any applicable circular of information for indications, contraindications, warnings and a list of possible adverse reactions.

• Marginal note:Autologous blood

  (2) In addition to the information required by subsection (1), the establishment must ensure that all of the following information appears on the label of autologous blood:

  • (a) the statement “For Autologous Use Only”;

  • (b) if the test results indicate that the blood is positive for a transmissible disease or disease agent listed in section 12.3.1.2 of the standard, a symbol or words to indicate that the blood is a biohazard; and

  • (c) if the blood has not been tested for the transmissible diseases and disease agents listed in section 12.3.1.2 of the standard, an indication to that effect.

• Marginal note:Contents of label — blood for use in manufacture of drug for human use

  (3) An establishment must ensure that all of the following information appears on the label of blood that is for use in the manufacture of a drug for human use:

  • (a) the name, civic address and licence number of the establishment that collected the blood;

  • (b) the donation code; and

  • (c) the statement “Caution: For Manufacturing Use Only”.