Marginal note:Additional information required
33. A registered establishment that imports and distributes, or that only distributes, a cell or tissue must ensure that the following information is added to that required by sections 30 and 31:
(a) on the exterior label and in the package insert, the name of the establishment, its civic address and contact information; and
(b) on the exterior label and in the package insert, the establishment’s registration number.
Marginal note:Quarantine — cells and tissues
34. (1) A source establishment must ensure that cells, except islet cells, and tissues are quarantined until all of the following processing activities are completed:
(a) the donor is found to be suitable after completion of the donor suitability assessment;
(b) except in the case of fresh skin, bacteriological test results are reviewed and found to be acceptable, if applicable; and
(c) all processing records are reviewed for completeness and compliance with the standard operating procedures.
Marginal note:Additional requirement — live donors of tissue
(2) In addition to the requirements set out in subsection (1), the source establishment must quarantine tissues that are retrieved from live donors in accordance with section 17.2 of the tissue standard.
Marginal note:Storage limits
35. An establishment that distributes cells, tissues or organs and that stores cells, tissues and adjunct vessels that were not used at the time of transplantation of the organ with which they were retrieved must observe scientifically based maximum storage periods.
Marginal note:Storage location
36. An establishment that distributes cells, tissues or organs must store them in a location that has appropriate environmental conditions that maintain their safety and that is secure against the entry of unauthorized persons.
Marginal note:Storage during transportation
37. An establishment that ships cells, tissues or organs must ensure that they are stored during transportation in appropriate environmental conditions.
Marginal note:Segregation — tissues
38. An establishment that stores tissues must ensure that those that are intended for autologous use are segregated from those intended for allogeneic use.
Marginal note:Segregation — transmissible disease agents and markers
39. An establishment that stores cells, tissues or organs must ensure that any of them that are untested or for which the results of tests on donor blood samples are positive or reactive for transmissible disease agents or markers or are unavailable are segregated from all other cells, tissues and organs.
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