Section 1609 Of Article 3. Biologics Other Than Human Whole Blood And Human Whole Blood Derivatives From California Health And Safety Code >> Division 2. >> Chapter 4. >> Article 3.

. No person shall engage in the production of biologics other than human whole blood and human whole blood derivatives unless:
  (a) In a laboratory licensed by the Public Health Service, United States Department of Health, Education and Welfare.
  (b) In a laboratory licensed by the Animal Inspection and Quarantine Branch, Agricultural Research Service, United States Department of Agriculture.
  (c) Under the provisions of this chapter.