Food and Drug Regulations (C.R.C., c. 870)

C.04.414. No person shall add a preservative or additive to source plasma.

C.04.415. A fabricator shall place source plasma in a container

• (a) in respect of which a medical device licence has been issued under the Medical Devices Regulations for the purpose of collecting and storing plasma;

• (b) that permits visual, electronic or automated inspection of the plasma;

• (c) that has been visually inspected at the plasmapheresis session and found to be intact; and

• (d) that has not been previously used for any purpose, including holding source plasma from the same donor.

• 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.

• C.04.417. (1) In respect of the storage of source plasma, including storage during transportation, a fabricator shall ensure that the storage environment

  • (a) is designed to maintain a temperature of -20°C or colder; and

  • (b) remains consistently at a temperature of -20°C or colder.

• (2) If the temperature of the environment rises above -20°C, the fabricator shall record the following information:

  • (a) the reason for the elevated temperature;

  • (b) the source plasma affected; and

  • (c) the final disposition of the source plasma.

• (3) If the temperature of the environment rises to between - 20°C and +10°C, the fabricator shall clearly and permanently label the container of the source plasma with the statement “Source Plasma — Salvaged” or “Plasma destiné au fractionnement — recyclé”.

• (4) Subsection (3) does not apply if the temperature of the environment rises to between -20°C and -5°C for a single period lasting less than 72 hours.

• (5) If the temperature of the environment rises above +10°C, the fabricator shall dispose of the source plasma.

• (6) Paragraph (1)(b) and subsections (2) to (5) do not apply in respect of the storage of source plasma during transportation, if the transportation is not conducted by the fabricator.