Section § 9241

Explanation

This law section makes it clear that you cannot sell or use certain biological products unless they meet specific licensing and regulatory requirements. To sell or use a biologic, it must be manufactured under a valid license from the United States Department of Agriculture. Similarly, blood or blood components must be produced in a licensed establishment or meet other specified legal standards, including requirements under the Business and Professions Code or proper importation and registration with the state.

No person shall offer for sale or use any of the following:
(a)CA Food And Agriculture Code § 9241(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)CA Food And Agriculture Code § 9241(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.

Section § 9242

Explanation

This law section requires that the secretary registers a blood or blood component product if it meets specific criteria. The product must be made using acceptable methods, shown to be safe and not harmful to animals, proven valuable for its intended use, properly labeled, and produced in a compliant facility.

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

Section § 9244

Explanation

This section outlines the requirements for registering a blood or blood component product in California. To apply, you must provide the owner’s and overseer’s names and addresses, the types of animal blood products sold, a detailed description of the production facility, production methods, and a sample label. A $500 fee is required for each product, which covers the application and annual renewal, due by July 1 each year. Fees are subject to annual inflation adjustments and may be changed by the department but only to cover reasonable regulatory costs.

(a)CA Food And Agriculture Code § 9244(a) An application for registration of blood or a blood component product shall include all of the following:
(1)CA Food And Agriculture Code § 9244(a)(1) The name and address of the person who owns the property, establishment, institution, or business that sells the blood.
(2)CA Food And Agriculture Code § 9244(a)(2) The name and address of the person who oversees the production of animal blood and blood component products.
(3)CA Food And Agriculture Code § 9244(a)(3) The type of animal blood and blood component products produced for sale.
(4)CA Food And Agriculture Code § 9244(a)(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)CA Food And Agriculture Code § 9244(a)(5) A protocol of the methods of production in detail that is followed in the production of the product.
(6)CA Food And Agriculture Code § 9244(a)(6) A sample of the label to be placed on the blood or blood component product.
(b)CA Food And Agriculture Code § 9244(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)CA Food And Agriculture Code § 9244(b)(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)CA Food And Agriculture Code § 9244(b)(2) Registration shall be renewed every year. The annual renewal fee shall be paid on or before July 1 of each year.
(3)CA Food And Agriculture Code § 9244(b)(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)CA Food And Agriculture Code § 9244(b)(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.

Section § 9245

Explanation

The secretary has the authority to set conditions on how blood and its components are produced and used to ensure the goals of the chapter are met.

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.