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MA H4298
Bill
Status
5/5/2025
Primary Sponsor
James O'Day
Click for details
AI Summary
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Prohibits manufacturing, selling, or distributing intravenous solution containers with intentionally added DEHP (di(2-ethylhexyl) phthalate) in Massachusetts beginning January 1, 2030, with IV tubing restrictions following on January 1, 2035
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Bans replacing DEHP with any other ortho-phthalate chemical in new or revised medical devices, listing 11 specific prohibited substitute chemicals including BBP, DBP, and DINP
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Sets maximum contamination threshold of 0.1% weight per weight for unintentionally added DEHP in IV containers and tubing products
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Exempts human blood collection and storage bags, as well as apheresis and cell therapy blood kits and bags including integral tubing
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Allows manufacturers a 2-year extension (to January 1, 2032) for IV containers if awaiting FDA approval or lacking adequate equipment, provided they notify Massachusetts customers by October 1, 2025 and publicly announce the delay by January 1, 2028
Legislative Description
Relative to toxic-free medical devices
Last Action
Reported favorably by committee and referred to the Joint Committee on Health Care Financing
11/13/2025