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
"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
"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
"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.