
Pennsylvania Sets DEHP Phase-Out Dates For IV Containers And Tubing
Pennsylvania Act 98 sets phased restrictions on intentionally added DEHP in IV containers and tubing, with exemptions and a conditional container extension.
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Pennsylvania enacted Senate Bill 804 as Act 98 of 2026 on 22 October. The law restricts di(2-ethylhexyl) phthalate, or DEHP, in intravenous solution containers and tubing. Its restrictions have different start dates and include exemptions. Legislative history.
Different Dates For Containers And Tubing
From 1 January 2030, the law prohibits manufacturing, selling or distributing IV solution containers made with intentionally added DEHP, subject to a conditional extension. The equivalent restriction for IV tubing begins on 1 January 2035. Section 58A14(a)–(b).
The medical-device chapter takes effect 90 days after enactment. It also prohibits replacing DEHP with another ortho-phthalate in a new or revised medical device. IV solution containers and tubing must not contain unintentionally added DEHP at or above 0.1% by weight. Sections 58A14(c)–(d) and 6.
Blood Products And A Conditional Extension
Human blood collection and storage bags are exempt from section 58A14. Apheresis and cell-therapy blood kits and bags, including integral tubing, are also exempt. Section 58A14(e).
The IV-container deadline can extend to 1 January 2032 where approval from the US Food and Drug Administration is pending for a DEHP-free container or the manufacturer lacks adequate production equipment. Both notice conditions must also be met:
- Notify Pennsylvania customers by 31 December 2026 that development of a DEHP-free container has started.
- Notify those customers and post publicly online by 1 January 2028 that the 2030 deadline will not be met.
From Bill To Enacted Law
SB 804 was introduced on 4 June 2025. The House amended it on 20 October 2026, passed it on 21 October, and the Senate concurred that day. The governor approved it on 22 October. Official bill history.
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Questions about this change
When does Pennsylvania Act 98 restrict DEHP in IV containers and tubing?
The intentionally added DEHP restrictions begin on 1 January 2030 for IV solution containers and 1 January 2035 for IV tubing. The container deadline can extend to 1 January 2032 only where the statutory grounds and both customer-notice conditions are met.
Does Pennsylvania Act 98 exempt blood collection bags from its DEHP restrictions?
Yes. Section 58A14 exempts human blood collection and storage bags, and apheresis and cell-therapy blood kits and bags, including integral tubing. These are exemptions from that section, not a general exemption for all medical devices.
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