Learn About The Law
Get help with your legal needs
FindLaw’s Learn About the Law features thousands of informational articles to help you understand your options. And if you’re ready to hire an attorney, find one in your area who can help.
Current as of January 01, 2025 | Updated by Findlaw Staff
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.
Cite this article: FindLaw.com - California Code, Health and Safety Code - HSC § 1609 - last updated January 01, 2025 | https://codes.findlaw.com/ca/health-and-safety-code/hsc-sect-1609/
FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.
A free source of state and federal court opinions, state laws, and the United States Code. For more information about the legal concepts addressed by these cases and statutes, visit FindLaw’s Learn About the Law.
Get help with your legal needs
FindLaw’s Learn About the Law features thousands of informational articles to help you understand your options. And if you’re ready to hire an attorney, find one in your area who can help.
Search our directory by legal issue
Enter information in one or both fields (Required)