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

Regulations are current to 2014-09-01 and last amended on 2014-08-21. Previous Versions

 No person shall sell a preparation from human sources unless both the inner and the outer labels clearly indicate that the preparation is derived from human sources.

 The expiration date for preparations from human sources issued in fluid or dried form shall be not later than five years after the date of filling the immediate container.

 The date of manufacture of preparations from human sources shall be the date of bleeding the donor.

 [Repealed, SOR/81-335, s. 3]

Human Plasma Collected by Plasmapheresis

Interpretation

 The following definitions apply in this section and in sections C.04.401 to C.04.423.

“accident”

“accident” means an unexpected event that is not attributable to a deviation from a fabricator’s procedures or applicable laws and that could adversely affect the safety of a donor or the safety, efficacy or quality of plasma. (accident)

“donor”

“donor” means a person aged 17 years or older who has given their name to a fabricator for the purpose of participating in plasmapheresis with that fabricator. (donneur)

“error”

“error” means a deviation from a fabricator’s procedures or applicable laws that could adversely affect the safety of a donor or the safety, efficacy or quality of plasma. (manquement)

“fabricator”

“fabricator” means a person who is the holder of an establishment licence issued under these Regulations that authorizes the person to fabricate source plasma. (manufacturier)

“personal identifier”

“personal identifier” means a unique group of letters, numbers or symbols, or any combination of them, that is assigned to a donor by a fabricator. (identificateur personnel)

“physician”

“physician” means a person who is entitled to practise the profession of medicine under the laws of the province in which the person provides medical service in connection with plasmapheresis or specific immunization. (médecin)

“physician substitute”

“physician substitute” means a person who

  • (a) acts under the general supervision and direction of a physician; and

  • (b) is authorized to provide the services that may be provided by a physician substitute under sections C.04.401 to C.04.423, according to the applicable laws of the province in which the person provides any of those services. (substitut)

“plasmapheresis”

“plasmapheresis” means a process during which:

  • (a) blood is taken from a donor from which plasma is separated; and

  • (b) red blood cells and formed elements from the blood are returned to the donor. (plasmaphérèse)

“plasmapheresis session”

“plasmapheresis session” means a meeting between a fabricator and a donor held for the purpose of proceeding with plasmapheresis. (séance de plasmaphérèse)

“serious adverse reaction”

“serious adverse reaction” means an unexpected and undesirable response in a donor, associated with plasmapheresis or specific immunization, that results in any of the following consequences for the donor:

  • (a) hospitalization;

  • (b) persistent or significant disability or incapacity;

  • (c) a medical or surgical intervention to preclude a persistent or significant disability or incapacity;

  • (d) a life-threatening condition; or

  • (e) death. (effet indésirable grave)

“source plasma”

“source plasma” means human plasma collected by plasmapheresis that is intended for use in producing a drug for human use. (plasma destiné au fractionnement)

“specific immunization”

“specific immunization” means the administration of an immunogen to a donor with the intention of eliciting an immune response in their blood for the purpose of plasmapheresis. (immunisation spécifique)

“unique identifier”

“unique identifier” means a unique group of letters, numbers or symbols, or any combination of them, that is assigned by a fabricator to source plasma or red blood cells to be used in specific immunization. (identificateur unique)

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