Food and Drug Regulations (C.R.C., c. 870)
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Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions
Preservatives and Additives
C.04.414. No person shall add a preservative or additive to source plasma.
- SOR/78-545, s. 1;
- SOR/85-1022, s. 6;
- SOR/2006-353, s. 1.
Containers
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.
- SOR/78-545, s. 1;
- SOR/85-1022, s. 6;
- SOR/2006-353, s. 1.
Labelling
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.
- SOR/78-545, s. 1;
- SOR/85-1022, s. 7;
- SOR/2006-353, s. 1.
Storage
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.
- SOR/78-545, s. 1;
- SOR/85-1022, s. 8;
- SOR/2006-353, s. 1.
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