Section 9221. (Amended by Stats. 2003, Ch. 62, Sec. 100.)
Cite as: Cal. Food & Agric. Code §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.