§ 109052. — 109052. (Added by Stats. 2024, Ch. 562, Sec. 1.)

California § 109052.

• Jurisdiction: California
• Code HSC: Health and Safety Code - HSC
• Div. 104.: DIVISION 104. ENVIRONMENTAL HEALTH
• Part 3.: PART 3. PRODUCT SAFETY
• Ch. 18.: CHAPTER 18. Chemicals in Medical Devices

Text

(a)
Commencing January 1, 2030, a person or entity shall not manufacture, sell, or distribute into commerce in the State of California intravenous solution containers made with intentionally added DEHP.
(b)
Commencing January 1, 2035, a person or entity shall not manufacture, sell, or distribute into commerce in the State of California intravenous tubing made with intentionally added DEHP.
(c)
A person or entity shall not replace DEHP, pursuant to this chapter, for revised or new products with other ortho-phthalates.
(d)
An intravenous
solution container or intravenous tubing product shall not have unintentionally added DEHP present at a quantity at or above 0.1 percent weight per weight (w/w).
(e)
The following items, as described in Title 21 of the Code of Federal Regulations, are exempt from these provisions:
(1)
Human blood collection and storage bags.
(2)
Apheresis and cell therapy blood kits and bags, including integral tubing.
(f)
A person or entity, due to pending United States
Food and Drug Administration approval for the DEHP-free intravenous solution container or due to the manufacturer not having adequate equipment to manufacture the DEHP-free intravenous solution container, shall meet the requirement in subdivision (a) by January 1, 2032, if all of the following conditions are met:
(1)
The person or entity notified its California customers, no later than July 1, 2025, that it has commenced development of the DEHP-free intravenous solution container to meet the requirements of this section.
(2)
The person or entity provides notice to its customers and posts to its official internet website, no later than January 1, 2028, that it will not meet the deadline imposed pursuant to subdivision (a).

Legislative History

Added by Stats. 2024, Ch. 562, Sec. 1. (AB 2300) Effective January 1, 2025.