Commercial Blood Banks for Animals and BiologicsBlood Or Blood Component Product Registration
Section § 9241
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.
Section § 9242
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.
Section § 9244
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.
Section § 9245
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.