Health and Safety Code section 1609

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)

In a clinical trial site storing or preparing for patient administration biologics, other than human whole blood and human whole blood derivatives, intended solely for investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of drugs or devices if the investigation is conducted in accordance with the requirements of Section 505(i) of the federal Food, Drug, and Cosmetic Act (21 U.S.C. Sec. 355(i)) or Section 520(g) thereof (21 U.S.C. Sec. 360j(g)) and the regulations adopted pursuant to the federal act.

(d)

Under the provisions of this chapter.

Source: Section 1609, https://leginfo.­legislature.­ca.­gov/faces/codes_displaySection.­xhtml?lawCode=HSC§ionNum=1609.­ (updated Jan. 1, 2023; accessed Aug. 25, 2025).

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Verified:
Aug. 25, 2025

§ 1609's source at ca​.gov