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Code · North Carolina · Chapter 130A — Public Health

§ 130A-453.42. Prohibitions.

304 words·~1 min read·/nc/chapter-130a/130a-453-42

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§ 130A-453.42. Prohibitions.
(a)Intravenous Solution Containers. - Beginning January 1, 2030, a person or entity shall not sell or distribute into commerce in the State of North Carolina intravenous solution containers made with intentionally added DEHP.
(b)Intravenous Tubing. - Beginning January 1, 2035, a person or entity shall not manufacture, sell, or distribute into commerce in the State of North Carolina intravenous tubing made with intentionally added DEHP.
(c)Replacement. - A person may not replace DEHP, pursuant to this Article, with another ortho-phthalate in a new or revised medical device.
(d)Maximum Quantity. - 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)Exemptions. - 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)Delayed Compliance. - 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 subsection
(a)of this section by January 1, 2032, if all of the following conditions are met:
(1)The person or entity notified its North Carolina customers, no later than October 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 website, no later than January 1, 2028, that it will not meet the deadline imposed pursuant to subsection
(a)of this section. (2025-25, s. 29(5); 2025-60, s. 3(a).)
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