Article 5. Blood Or Blood Component Product Registration of California Food And Agricultural Code >> Division 5. >> Part 1. >> Chapter 1.5. >> Article 5.

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.

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.

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.

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.