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

Regulations are current to 2014-09-15 and last amended on 2014-08-21. Previous Versions

 A fabricator shall not use a person to serve as a donor of blood, placenta, or cord who has a history of a disease transmissible by blood transfusion including syphilis, infectious hepatitis, or malaria.

  • SOR/97-12, s. 61.

 The operation of drawing blood from a donor shall be under the supervision of a qualified medical practitioner, and shall be carried out in a suitable bleeding room under the control of the fabricator.

  • SOR/97-12, s. 61.

 A fabricator shall obtain human placenta and cord used in the manufacture of preparations from human sources only from women confined in public hospitals, and the donor of such placenta and cord shall have been free from the toxaemias of pregnancy, and the placenta and cord shall not show gross evidence of any pathological condition.

  • SOR/97-12, s. 61.
  •  (1) Subject to subsections (2) and (3), dried human serum, dried human plasma or dried fractions of either shall not contain more than one per cent moisture when determined by an acceptable method.

  • (2) Dried Rho(D) Immune Human globulin shall not contain more than three per cent moisture when determined by an acceptable method.

  • (3) Dried Antihemophilic Factor Human shall not contain more than two per cent moisture when determined by an acceptable method.

  • SOR/81-334, s. 3.

 A fabricator shall provide directions or means for the removal of particles of such size as to be dangerous to the recipient from preparations from human sources that are issued in fluid form or that are reconstituted from the dried form.

  • SOR/97-12, s. 61.

 A fabricator of preparations from human sources shall maintain complete records of all donors, which records shall include the medical certificate required by section C.04.231.

  • SOR/97-12, s. 61.

 A fabricator, packager/labeller or distributor referred to in paragraph C.01A.003(b) may issue human serum or human plasma, or fractions of either of them, for prophylactic or therapeutic use in any of the following forms:

  • (a) immune human serum, which shall be serum separated from the blood of persons recovered from the disease or from persons specifically immunized against the disease for which the serum is intended as a prophylactic or therapeutic agent;

  • (b) immune human globulins, or other immune human serum fractions, which shall be prepared from immune human serum or plasma;

  • (c) normal human serum, or normal human plasma, or fractions of either of these prepared from the blood of normal individuals; and

  • (d) dried products prepared from any of these.

  • SOR/97-12, s. 46.