North Carolina, USA, Regulates DEHP in Certain Medical Devices

SafeGuardSPersonal and Protective EquipmentAug 13, 2025

SG 119/25

The US state of North Carolina has banned intentionally added di(2-ethylhexyl) phthalate (DEHP) in intravenous bags and tubing.

On July 3, 2025, the governor of North Carolina signed SB 600 (session law 2025-60) into law to regulate DEHP in intravenous (IV) solution containers and IV tubing. This amendment adds ‘Article 19C, DEHP Hazard Management’ to Chapter 130A of the state’s General Statute in relation to Public Health.

According to the definitions in the new law:

‘IV solution container’ means 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
‘IV tubing’ means tubing used to intravenously administer fluids, medication or nutrients directly to an adult, child or infant
‘Ortho-phthalate’ means a class of chemicals that are esters of ortho-phthalic acid, including all the chemicals listed in Table 2

Key highlights of SB 600 are summarized in Table 1.

Substance	Scope	Requirement	Effective date
DEHP	IV solution containers (IV bags)	Prohibited if intentionally added^1,2 < 0.1%, if unintentionally added	January 1, 2030³
DEHP	IV tubing	Prohibited if intentionally added^1,2 < 0.1%, if unintentionally added	January 1, 2035
¹Prohibited to replace DEHP with another ortho-phthalate (see Table 2) in a new or refurbished medical device ²Exempts 1) human blood collection and storage bags and 2) apheresis and cell therapy blood kits and bags, including integral tubing ³Effective date of January 1, 2032, applies to manufacturers awaiting US Food and Drug Administration (FDA) approval of DEHP-free IV bags if manufacturer meets the following requirements: 1) manufacturer must notify its North Carolina customers by October 1, 2025, about its development of DEHP-free IV bags meeting the requirements of this law, and 2) manufacturer must provide notice to customers and post this to its website by January 1, 2028, that the original deadline of January 1, 2030, cannot be met

Table 1

Item	Abbreviation	Ortho-phthalate	Item	Abbreviation	Ortho-phthalate
1	BBP	Benzyl butyl phthalate	7	DIDP	Diisodecyl phthalate
2	DBP	Dibutyl phthalate	8	DINP	Diisononyl phthalate
3	DCHP	Dicyclohexyl phthalate	9	DnHP	Di-n-hexyl phthalate
4	DEP	Diethyl phthalate	10	DNOP	Di-n-octyl phthalate
5	DEHP	di(2-ethylhexyl) phthalate	11	DnPP	Di-n-pentyl phthalate
6	DIBP	Diisobutyl phthalate	12	DIHP	Diisoheptyl phthalate

Table 2. Ortho-phthalates

North Carolina now joins California in regulating DEHP in IV bags and tubing (SafeGuardS 154/24).

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