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4. Requirements for Product Registration

Requirements for Product Registration

Community blood banks operating in California must register with the California Veterinary Medical Board (BPC 4920.4).

All animal blood and blood component products must be registered with the California Department of Food and Agriculture (BPC 4920.5). Registration must be renewed annually. An application for registration of blood or a blood component product shall include all the following (FAC 9244 (a) (1-6)):

• The name and address of the person who owns the property, establishment, institution, or business that sells the blood
• The name and address of the person who oversees the production of animal blood and blood component products
• The type of animal blood and blood component products produced for sale
• 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
• A protocol of the methods of production in detail that is followed in the production of the product
• A sample of the label to be placed on the blood or blood component product
• Establishments must notify regulators about each change in the product, production process, quality control, equipment, facilities, person responsible for overseeing production, or labeling.

The annual product registration fee is $500 for each product (FAC section 9244(b)(1).

Product registration fees should be made payable to "CDFA-904" and note CDFA Program Code – 9999000A47 on the check memo.

Send the payment to:
Cashier California Department of Food and Agriculture
Post Office Box 942881
Sacramento, California 94271

Please email product registration documents to CDFAbloodbanks@cdfa.ca.gov or mail to:
CDFA Animal Health and Food Safety Services
Attn: Dr. Sean Brady
1220 N Street
Sacramento, CA 95814