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

  • C.04.404. (1) A fabricator shall not proceed with plasmapheresis or specific immunization unless a physician or physician substitute has determined the donor’s suitability to participate in plasmapheresis more frequently than once every eight weeks based on the donor’s medical history and a medical examination of the donor.

  • (2) If the donor is determined to be suitable, the fabricator shall document the following information:

    • (a) the fact that the donor is suitable to participate in plasmapheresis more frequently than once every eight weeks;

    • (b) the donor’s name and personal identifier;

    • (c) the name and signature of the physician who makes the determination, or supervises the physician substitute making the determination; and

    • (d) the date of the determination.

  • (3) The fabricator shall not proceed with plasmapheresis or specific immunization if the most recent determination under subsection (1) in respect of the donor was made more than

    • (a) 30 days before the date set for the donor’s first participation in plasmapheresis or specific immunization; or

    • (b) one year before any other date set for the donor’s participation in plasmapheresis or specific immunization.

  • SOR/78-545, s. 1;
  • SOR/85-1022, s. 3;
  • SOR/2006-353, s. 1.
Previous Version

Specific Immunization

  • C.04.405. (1) No one other than a physician or physician substitute shall administer an immunogen to a donor for the purpose of specific immunization.

  • (2) A physician shall monitor the donor’s response to the immunogen to determine if the donor can continue to receive specific immunization.

  • (3) If the donor cannot continue to receive specific immunization, the fabricator shall cease to provide it to the donor until a physician determines that the donor can receive specific immunization using the same or another immunogen.

  • SOR/78-545, s. 1;
  • SOR/85-1022, s. 3;
  • SOR/2006-353, s. 1.
Previous Version

Evaluation Before Collection

  • C.04.406. (1) At the beginning of each plasmapheresis session, a physician or physician substitute shall determine if the donor is suitable to participate in plasmapheresis.

  • (2) If the donor is determined to be temporarily not suitable to participate in plasmapheresis based on the criteria set out in Table 1 or any other medical reason justifying a determination of temporary non-suitability, the fabricator shall cancel the session, inform the donor of the reason why they are temporarily not suitable and indicate the date when the donor may continue to participate in plasmapheresis.

  • (3) If the donor is determined to be not suitable to participate in plasmapheresis for an indefinite period based on the exclusion criteria set out in Table 2 or any other medical reason justifying a determination of indefinite non-suitability, the fabricator shall cancel the session and inform the donor of the reason why they are not suitable to participate in plasmapheresis for an indefinite period.

    TABLE 1

    ItemCriteria
    1.Weight of less than 50 kg
    2.Temperature outside of normal limits
    3.Blood pressure above 100 mmHg diastolic or 180 mmHg systolic
    4.Haemoglobin level of less than 125 g/L of blood or haematocrit value of less than 0.38 L/L of blood
    5.Total protein level of less than 60 g/L of blood
    6.Substantial blood loss
    7.Prior donation of plasma or other blood components
    8.Pregnancy
    9.History of medical or surgical procedures
    10.History of convulsions requiring medical treatment
    11.Ability to answer questions compromised by alcohol or drug use
    12.Prior transfusion of blood, blood components or a blood product, or prior transplantation of a cell, tissue or organ other than dura mater
    13.Skin infection at the site of the phlebotomy
    14.Sign or symptom of infection
    15.Risk of infection with HIV, hepatitis B virus or hepatitis C virus based on, but not limited to, a history of acupuncture, skin piercing, tattooing, accidental needle-stick injury or occasional sexual relations with a person at risk of having any of those infections
    16.Current or past use of medication that poses a risk to a recipient of a product manufactured from source plasma
    17.Receipt of a live attenuated vaccine
    18.Animal bite requiring prophylaxis for rabies or for which the need for post-exposure prophylaxis has not been assessed

    TABLE 2

    ItemExclusion Criteria
    1.Abnormal cardiovascular function or serious or chronic cardiovascular disease
    2.Abnormal respiratory function or serious or chronic respiratory disease
    3.Bleeding disorder that poses a risk to the donor in relation to plasmapheresis
    4.Serious disease or medical condition of the liver, kidneys, another organ, a system or blood
    5.Persistent abnormal plasma proteins including monoclonal or polyclonal gammopathy
    6.Current or past use of medication that poses an ongoing risk to a recipient of a product manufactured from source plasma
    7.History of recurrent fainting associated with the donation of blood or plasma
    8.History, signs or symptoms of injectable drug abuse such as skin punctures, scars or sharing needles to inject drugs
    9.History, signs or symptoms of AIDS or HIV infection
    10.Risk of HIV infection based on sexual practices
    11.History, signs or symptoms of a chronic or persistent infection or parasitic disease transmissible by blood
    12.History, signs or symptoms of hepatitis, other than hepatitis A
    13.Cancer, other than non-melanoma skin cancer or in-situ cervical cancer
    14.Risk factor for Creutzfeldt-Jacob disease (CJD) or its variant (vCJD) based on, but not limited to, the receipt of dura mater transplant or a treatment using a human pituitary hormone
    15.Positive test result for any transmissible disease agent
  • SOR/78-545, s. 1;
  • SOR/85-1022, s. 3;
  • SOR/2006-353, s. 1.
Previous Version