SECTIONS 9221 - California Statutes

FOOD AND AGRICULTURAL CODE

SECTION 9221

9221. An application for a license for any establishment that
produces, or proposes to produce, biologics shall be made on forms to
be issued by the secretary. The application shall contain all of the
following:
(a) The name and address of the person who owns the place,
establishment, or institution in which it is proposed to produce
biologics.
(b) The name and address of the person who shall be in charge of
biologics production.
(c) The type of biologics that shall be produced.
(d) A full description of the building, including its location,
facilities, equipment, and apparatus to be used in biologics
production.
(e) A written protocol for a commercial blood bank for animals
that addresses all of the following:
(1) Maximum length of time for donation by animal donors, or
minimum health parameters for animal donors.
(2) Frequency and volume of blood collected from animal blood
donors.
(3) Socialization and exercise programs for animal blood donors.
(4) Method of identification of each animal, including microchip
or tattoo.
(5) Ongoing veterinary care, including an annual physical exam and
vaccination schedule for animals held in blood donor facilities.
(6) Husbandry standards for feeding, watering, sanitation,
housing, handling, and care in transit, with minimums based on the
standards set forth pursuant to the federal Animal Welfare Act in
Part 3 (commencing with Section 3.1) of Subchapter A of Chapter 1 of
Title 9 of the Code of Federal Regulations.
(7) Implementation of a permissive adoption program.
(f) An "oversight letter" identifying the oversight veterinarian
who will be responsible for oversight of the facility. The letter
shall be from the oversight veterinarian, and shall be maintained on
file by the secretary. Oversight veterinarians shall be licensed to
practice veterinary medicine in California. In the event of a change
of the oversight veterinarian, it is the oversight veterinarian's
responsibility to give notice to the secretary of the termination of
the oversight veterinarian within 30 days of the termination date of
the oversight veterinarian. An oversight letter from the incoming
oversight veterinarian shall be submitted to the secretary within 30
days of the termination date of the prior oversight veterinarian.
(g) Additional information that the secretary finds is necessary
for the proper administration and enforcement of this chapter.