Article 1. Definitions of California Health And Safety Code >> Division 2. >> Chapter 4. >> Article 1.

Unless the context otherwise requires, the definitions in this article govern the construction of this chapter.

"Biologics" includes the following products which are offered for sale or distribution for the prevention or treatment of disease, except biologics which are registered pursuant to Chapter 1.5 (commencing with Section 9201), Part 1, Division 5 of the Food and Agricultural Code:
  (a) Human whole blood.
  (b) Human whole blood derivatives specified by regulations.
  (c) Serum, vaccine, live vaccine, killed vaccine, tissue vaccine, autogenous vaccine, live virus, killed virus, live bacterial culture, killed bacterial culture, bacterin, hormone, tissue extract, gland extract, gland preparation, insulin, and similar products made from human or animal tissues or micro-organisms. The amendments to this section enacted at the 1973-74 Regular Session of the Legislature shall become operative on July 1, 1975.

"Blood bank" means any place where human whole blood, and human whole blood derivatives specified by regulation, are collected, prepared, tested, processed, or stored, or from which human whole blood or human whole blood derivatives specified by regulation are distributed.

"Blood collection center" means a stationary auxiliary to a blood bank which is designed, equipped, and staffed to procure human whole blood or blood components which are to be transported to the blood bank for processing, storing, and distribution.

"Stationary" means a nonmobile room or building maintained at a fixed address.

"Mobile unit" means a transportable auxiliary to a blood bank designed, equipped, and staffed to procure human whole blood and to transport this blood to the bank for processing, storing, and distribution.

"Blood bank depository" means any place other than a blood bank where human whole blood and human whole blood derivatives specified by regulation are stored and held for transfusion. Such blood bank depositories shall be clinical laboratories, licensed in accordance with the provisions of Chapter 3 (commencing with Section 1200), Division 2 of the Business and Professions Code, or such other places where services essentially equivalent are maintained, as determined by the department.

"Blood component" or "blood derivative" means any product produced from whole blood.

"Distribution" includes sale and exchange.

"Production" includes collection, preparation, testing, processing, storage, and distribution of biologics under a license issued by the department.

"Department" means the State Department of Health Services.

"Carrier donor" means any donor of human whole blood whose blood donation has been found, either by laboratory tests or by the tracing of a transfusion-associated hepatitis case where there was a single donor, to contain viral hepatitis, or any donor of human whole blood who has twice been determined by the department to be a possible carrier donor.

"Possible carrier donor" means any donor of human whole blood whose blood donation was administered where multiple transfusions from multiple donors were administered to a recipient and such transfusions result in a case diagnosed by a physician as transfusion-associated hepatitis.

"Carrier of viral hepatitis" means a person under treatment by a physician who has contracted viral hepatitis which has been confirmed by voluntary laboratory tests or who exhibits symptoms which lead a physician to render a diagnostic opinion that the person has contracted viral hepatitis.