Health & Saf. Code, § 1609 · Article 3. Biologics Other Than Human Whole Blood and Human Whole Blood Derivatives
Health & Saf. Code, § 1609
Text — As published in the Legislative Counsel's database, tables dated October 18, 2026 (pubinfo_2025.zip)
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.
Notes and commentary — not statutory text
History
Amended by Stats. 2022, Ch. 955, Sec. 2. (SB 1500) Effective January 1, 2023.
Source of truth
- Edition
- As published in the Legislative Counsel's database, tables dated October 18, 2026 (pubinfo_2025.zip)
- Official file
- https://leginfo.legislature.ca.gov/faces/codes_displaySection.xhtml?lawCode=HSC§ionNum=1609.
- Text hash
- sha256 95fb5db8ceb81fa6aecfe066f06ab6de265ce98ee09694923ecd5111c21dbec1
- Composed by
- compose_ca.py 2026-10-22: the Legislative Counsel's CAML content files read by a tokenizer (caml_readers.reader_a); an independent xml.etree reading (caml_readers.reader_b) agrees on every section
Cited by 1 provision
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Health and Safety Code
Procedural information only. Not legal advice and not a substitute for the advice of an attorney. Confirm the current text with the official publisher before relying on it.