Bill > SB804

This bill establishes new regulations regarding the use of DEHP (di(2-ethylhexyl) phthalate), a toxic chemical commonly used in medical devices, with the goal of reducing potential health risks. The legislation prohibits the manufacture, sale, and distribution of intravenous solution containers with intentionally added DEHP beginning January 1, 2027 (with a potential extension to 2032), and sets a phased approach for banning DEHP in intravenous tubing, starting with a ban in neonatal intensive care units and for nutrition and oncology treatments by 2027, and a complete ban by 2032. The bill requires healthcare practitioners to notify patients about the presence of DEHP or other ortho-phthalates in medical devices, including informing patients about associated health risks and their right to request DEHP-free alternatives. The legislation is based on scientific findings that DEHP may be an endocrine-disrupting compound linked to potential reproductive health issues, cancer risks, and other medical complications. The bill also prohibits replacing DEHP with other ortho-phthalates and sets a limit on unintentionally added DEHP at 0.1% weight per weight, with specific exemptions for certain medical equipment like blood collection and storage bags. Manufacturers can request an extension to the compliance deadline under certain conditions, such as pending FDA approval or manufacturing limitations.

Budget and Finance, Business and Industry

https://www.legis.state.pa.us/cfdocs/billinfo/bill_history.cfm?syear=2025&sind=0&body=S&type=B&bn=804