Food and Drug Regulations

C.04.403 (1) A fabricator shall not begin plasmapheresis with a donor unless

• (a) the fabricator has informed the donor of what is involved with plasmapheresis, including the risks to the donor’s health associated with plasmapheresis and with participating in plasmapheresis more frequently than once every eight weeks; and

• (b) after paragraph (a) has been satisfied, the fabricator obtains from the donor

  • (i) a written acknowledgement that the information specified in paragraph (a) has been provided to them, and

  • (ii) in accordance with the applicable laws governing consent, written informed consent to participate in plasmapheresis.

(2) A fabricator shall not begin the specific immunization of a donor unless

• (a) a physician has selected the immunogen to be administered to the donor and informed the donor of

  • (i) the name and nature of the selected immunogen,

  • (ii) the proposed frequency and the maximum number of specific immunization injections the donor is expected to receive, and

  • (iii) what is involved with specific immunization, including the risks to the donor’s health associated with specific immunization and with receiving the selected immunogen; and

• (b) after paragraph (a) has been satisfied, the fabricator obtains from the donor

  • (i) a written acknowledgement that the information specified in paragraph (a) has been provided to them, and

  • (ii) in accordance with the applicable laws governing consent, written informed consent to receive the selected immunogen.