Article 5 - Blood or Blood Component Product Registration

California Food and Agricultural Code — §§ 9241-9245

Sections (4)

Amended by Stats. 2021, Ch. 752, Sec. 17. (AB 1282) Effective January 1, 2022.

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 or in accordance with Article 7 (commencing with Section 4920) of Chapter 11 of Division 2 of the Business and Professions Code, or imported into the state pursuant to Section 9252 and registered with the department in accordance with Section 9244.

Amended by Stats. 2010, Ch. 235, Sec. 16. (AB 1709) Effective January 1, 2011. Became operative on January 1, 2013, pursuant to Sec. 28 of Ch. 235.

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.

Amended by Stats. 2021, Ch. 752, Sec. 18. (AB 1282) Effective January 1, 2022.

(a)An application for registration of blood or a blood component product shall include all of the following:
(1)The name and address of the person who owns the property, establishment, institution, or business that sells the blood.
(2)The name and address of the person who oversees the production of animal blood and blood component products.
(3)The type of animal blood and blood component products produced for sale.
(4)A full description of the building, including its address, facilities, equipment, and apparatus, to be used in production of animal blood and blood

component products.

(5)A protocol of the methods of production in detail that is followed in the production of the product.
(6)A sample of the label to be placed on the blood or blood component product.
(b)The registration application fee and annual renewal fee for an establishment proposing to offer blood or blood component products for retail sale or use in California shall be as follows:
(1)The registration application fee and annual renewal fee shall be five hundred dollars ($500) for each product, which shall be the fee for the fiscal year, or portion thereof, ending June 30 of each year.
(2)Registration shall be renewed every year. The annual renewal fee shall be paid on or

before July 1 of each year.

(3)The application and renewal fees under this chapter shall be adjusted annually for inflation. The adjustments shall be rounded off to the nearest whole dollar.
(4)Fees may be increased or decreased by the department but shall not exceed the department’s reasonable regulatory costs incurred to administer and enforce product safety standards set forth in this chapter.

Amended by Stats. 2010, Ch. 235, Sec. 19. (AB 1709) Effective January 1, 2011. Became operative on January 1, 2013, pursuant to Sec. 28 of Ch. 235.

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.