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

Regulations are current to 2013-06-10 and last amended on 2013-05-31. Previous Versions

Prohibitions

C.04.401. No person shall

  • (a) sell source plasma unless it has been fabricated, tested, packaged/labelled and stored in accordance with sections C.04.402 to C.04.423; or

  • (b) fabricate source plasma from blood collected from a person who is not suitable to participate in plasmapheresis according to sections C.04.402 to C.04.423.

  • SOR/78-545, s. 1;
  • SOR/85-1022, s. 2;
  • SOR/2006-353, s. 1.
Previous Version

Fabricator’s Responsibility

  • C.04.402. (1) A fabricator shall ensure that a person who provides services to them in connection with plasmapheresis or specific immunization is qualified by education and by training or experience to provide the services.

  • (2) The fabricator shall ensure that the premises used for donor screening, plasmapheresis or specific immunization are designed, constructed and maintained in a manner that permits medical information to be communicated in confidence.

  • SOR/78-545, s. 1;
  • SOR/85-1022, s. 2;
  • SOR/97-12, s. 47;
  • SOR/2006-353, s. 1.
Previous Version

Consent and Preliminary Evaluation

  • 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.

  • SOR/78-545, s. 1;
  • SOR/2006-353, s. 1.
Previous Version