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:
Key highlights of SB 600 are summarized in Table 1.
| Substance | Scope | Requirement | Effective date |
|---|---|---|---|
| DEHP |
|
| January 1, 20303 |
|
| 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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