SECTIONS 9241-9245 - California Statutes

FOOD AND AGRICULTURAL CODE

SECTION 9241-9245

9241. No person shall offer for sale or use any biologic unless it
is registered by the director pursuant to this article, except,
however, no such registration shall be required of any biologic
manufactured pursuant to the terms of a valid license issued by the
United States Department of Agriculture unless the director finds
that, due to local conditions, it is necessary that the biologic be
registered in order to assure that it have value for the purpose
intended and it is safe to use in this state.

9241. No person shall offer for sale or use any of the following:
(a) Any biologic unless it is manufactured pursuant to the terms
of a valid license or permit issued by the United States Department
of Agriculture.
(b) Any blood or blood component product unless it is produced in
an establishment licensed by the secretary.

9242. The director shall register any biologic that meets all of
the following requirements:
(a) It is produced under acceptable procedures, which include
tests to insure its purity and safety.
(b) The production and use of such type of biologic has not been
specifically forbidden or disapproved by the director, the United
States Department of Agriculture, or the United States Public Health
Service.
(c) It has been demonstrated to the director that such a biologic
is safe and noninjurious to human or animal health.
(d) It has been demonstrated to the director that such a biologic
is of value for the purpose intended.
(e) It is labeled for proper handling and use, and is not
misrepresented.
(f) It is produced in an establishment that meets the requirements
of subdivision (a) or (c) of Section 9211.

9242. The secretary shall register blood or a blood component
product that meets all of the following requirements:
(a) It is produced under acceptable procedures.
(b) It has been demonstrated to the secretary that the blood or
blood component product is safe and noninjurious to animal health.
(c) It has been demonstrated to the secretary that the blood or
blood component product is of value for the purpose intended.
(d) It is labeled for proper handling and use, and is not
misrepresented.
(e) It is produced in an establishment that meets the requirements
of Section 9210.

9243. The director shall register a biologic, if it is produced in
an establishment exempt from licensing pursuant to subdivision (b) of
Section 9211 and meets the requirements of subdivisions (a), (b),
and (c) of Section 9242.

9244. An application for registration of a biologic shall include
both of the following:
(a) A protocol of methods of production in detail which is
followed in the production of the product.
(b) A sample of the label to be placed on the biologic.

9244. An application for registration of blood or a blood component
product shall include both of the following:
(a) A protocol of the methods of production in detail that is
followed in the production of the product.
(b) A sample of the label to be placed on the blood or blood
component product.

9245. The director may impose such conditions on the production or
use of biologics as he deems necessary to accomplish the purposes of
this chapter.

9245. The secretary may impose such conditions on the production or
use of blood or blood component products as he or she deems
necessary to accomplish the purposes of this chapter.