North Carolina General Statutes Chapter 130A. Public Health § 130A-453.42. Prohibitions

Current as of January 01, 2023 | Updated by Findlaw Staff

(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.

Previous Part of Code Next Part of Code

Back to Chapter List

Cite this article: FindLaw.com - North Carolina General Statutes Chapter 130A. Public Health § 130A-453.42. Prohibitions - last updated January 01, 2023 | https://codes.findlaw.com/nc/chapter-130a-public-health/nc-gen-st-sect-130a-453-42/

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.

Was this helpful?

Welcome to FindLaw's Cases & Codes

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.

Go to Learn About the Law

Did FindLaw Help You Understand This Legal Issue?

Make It a Preferred Google Search Source

Add to Google

Latest Blog Posts

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.

Go to Learn About the Law

Need to Find an Attorney?

Search our directory by legal issue

Enter information in one or both fields (Required)