Food and Drug Regulations

C.04.404 (1) Every practitioner shall, within 30 days before carrying out on a donor a procedure in a plasmapheresis program involving collection of plasma at intervals of eight weeks or less,

• (a) determine the suitability of the donor for plasmapheresis by means of

  • (i) the review of the donor’s medical history, and

  • (ii) such tests and physical examination as the practitioner deems necessary; and

• (b) if the practitioner has determined pursuant to paragraph (a) that the donor is suitable for plasmapheresis, sign a certificate to that effect.

(2) Subsection (1) does not apply where a practitioner has, in respect of the donor, signed a certificate referred to in paragraph (1)(b) within the 12-month period preceding the date on which the procedure is to be carried out.