2007 California Food and Agricultural Code Article 2. Biologics Production

CA Codes (fac:9211-9212)

9211.  No person shall engage in the production of biologics except
in any of the following:
   (a) In an establishment licensed by the United States Department
of Agriculture.
   (b) In an establishment producing biologics only for use by the
owner or operator of that establishment for animals owned by him or
her.  Biologics produced in such an establishment shall be registered
by the director under this chapter.
   (c) In an establishment licensed by the director.



9212.  The secretary shall license biologic establishments that meet
all of the following:
   (a) Operate under conditions, and use methods of production, to
insure that the biologics will not be contaminated, dangerous, or
harmful.
   (b) Produce biologics under the direct supervision of a person
qualified in the field of production of biologics.
   (c) For those commercial blood banks for animals licensed by the
department, maintain onsite records containing information
documenting how the animal was acquired and any history of blood
draws or use of anesthesia on the animal.