TOXIC-FREE MEDICAL DEVICES ACT OF 2025.

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View NCGA Bill Details(link is external)2025-2026 Session
House Bill 592 (Public) Filed Monday, March 31, 2025
AN ACT TO PROHIBIT THE MANUFACTURING, SELLING, AND DISTRIBUTING OF INTRAVENOUS SOLUTION CONTAINERS AND INTRAVENOUS TUBING THAT ARE INTENTIONALLY MADE WITH DEHP.
Intro. by Reeder, Rhyne.
Status: Ref To Com On Rules and Operations of the Senate (Senate action) (Apr 28 2025)

Bill History:

H 592

Bill Summaries:

  • Bill H 592 (2025-2026)
    Summary date: Apr 15 2025 - View Summary

    House committee substitute to the 1st edition makes the following changes.

    Amends new GS 130A-453.34 as follows. Removes from the definition of intentionally added DEHP DEHP that is an intentional breakdown product of an added chemical. Adds and defines the term unintentionally added DEHP as DEHP in an intravenous solution container or intravenous tubing product that is not used for functional or technical effect on the product. 

    Amends proposed GS 130A-453.35 by adding that a person or entity, due to pending USFDA 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, must meet the requirements of the statute concerning the solution containers by January 1, 2032, if: (1) they notified their NC customers, no later than October 1, 2025, that it commenced development of the DEHP-free intravenous solution container to meet the statute's requirements and (2) it provides notice to its customers and posts to its website, by January 1, 2028, that it will not meet the January 1, 2030 deadline. 

    Health and Human Services, Health
    GS 130A
  • Bill H 592 (2025-2026)
    Summary date: Apr 2 2025 - View Summary

    Amends Chapter 130A adding Article 19C regarding Di(2-ethylhexyl) phthalate (DEHP) Hazard Management.

    Sets out 12 NCGA findings about DEHP and other ortho-phthalates that are toxic chemicals, DEHP’s common use in medical devices, and the potential harms of DEHP leaching and exposure to humans.

    Contains six definitions including DEHP, health care practitioner, intentionally added DEHP, intravenous solution container, intravenous tubing, and ortho-phthalate. Defines intentionally added DEHP as DEHP that a manufacturer intentionally added to a product that has a functional or technical effect on the product or DEHP that is an intentional breakdown product of an added chemical. Defines intravenous solution container as a container used to house medicine, fluid, or nutrition therapy that is intravenously delivered to a patient in a hospital, outpatient facility, or other healthcare facility. Defines intravenous tubing as tubing used to intravenously administer fluids, medication, or nutrients directly to an adult, child, or infant. Defines ortho-phthalate using a list of chemical classes.

    Prohibits any person or entity from manufacturing, selling, or distributing into commerce in the state: (1) intravenous solution containers made with intentionally added DEHP, beginning January 1, 2030; and (2) intravenous tubing made with intentionally added DEHP, beginning January 1, 2035. Prohibits a person from replacing DEHP with another ortho-phthalate in a new or revised medical device. Mandates that an intravenous solution container or intravenous tubing product cannot have unintentionally added DEHP present in a quantity at or above 0.1 percent weight per weight.

    Provides exemptions from these provisions for human blood collection and storage bags and apheresis and cell therapy blood kits and bags, including integral tubing.

    Makes conforming changes to GS 130A-22(b3) and adds a penalty cap of $5,000 per day a violation of Article 19C continues.

    Health and Human Services, Health
    GS 130A
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