Cal. Code Regs. tit. 17 § 1026
Since procedures and standards for the preparation of other blood fractions, such as immune serum globulin, albumin, etc., for transfusion purposes are not as yet well suited for blood bank production, any biologies producer operating under the license of the department shall submit a complete protocol of procedures to be followed and shall be subject to the current specifications of the department regarding such products. This shall include specific licensure for the production of such materials, inspection, and the maintenance of appropriate standards. Such standards as are necessary will, in general, follow the usual blood banking procures with deviations general, follow the usual blood banking procedures with deviations only for specific reason. Such deviations and specific procedures shall be outlined in writing to the department by the biologics producer. Potential producers of such biologics should avail themselves of the consultative services of this department in order to provide for a proper production procedure consistent with regulations of the department, thus avoiding the installation of methods which must later be amended or changed.
Cal. Code Regs. Tit. 17, § 1026