Concerning phthalates in medical equipment used for intravenous purposes.
What this bill does Powered by Legitron
This bill creates a new chapter in Title 70A RCW (sections 1–3) that prohibits, starting January 1, 2030, the manufacture, sale, or distribution in Washington of intravenous solution containers that contain DEHP intentionally or unintentionally at or above 0.1% weight/weight, and that similarly prohibits intravenous tubing with those DEHP levels beginning January 1, 2035. It also bars replacing DEHP with other ortho-phthalates in any product covered by the chapter.
The bill includes defined terms (DEHP; intentionally and unintentionally added DEHP; intravenous solution containers; intravenous tubing) and lists ortho-phthalates by name and CAS number. It exempts, per 21 C.F.R. as of January 1, 2026, human blood collection and storage bags and apheresis and cell therapy blood kits and bags (including integral tubing). It allows an extension for compliance for intravenous solution containers to January 1, 2032 if a manufacturer met two notice conditions by specified 2027–2028 dates, and it permits continued manufacture, distribution, and sale of FDA-approved DEHP-containing containers and tubing while the FDA or the Washington Department of Health determines an industry shortage exists, ending when those authorities determine the supply interruption is terminated. The bill also states it does not limit the Department of Ecology’s authority under chapter 70A.350 RCW.
The bill affects manufacturers, sellers, and distributors of the specified medical products and their Washington customers, and it references the FDA and Washington Department of Health for approvals and shortage determinations. The text provided does not specify the new chapter number, an enforcement agency, penalties or remedies for violations, the specific 21 C.F.R. provisions that create the exemptions, the procedures or criteria the FDA or Department of Health will use to determine a shortage or end a supply interruption, or testing and reporting standards for the 0.1% w/w threshold.
Why it matters Powered by Legitron
If enacted, manufacturers and suppliers will have to move away from DEHP in IV solution containers by 2030 (with a possible narrow extension to 2032 if they notify Washington customers by the specified 2027 and 2028 deadlines) and in IV tubing by 2035, and they may not substitute other ortho-phthalates. Certain blood collection/storage bags and apheresis and cell therapy kits and bags are exempt only as described in the federal rules in effect on January 1, 2026, and FDA or Washington Department of Health shortage findings can temporarily allow continued sale of FDA‑approved DEHP products until a shortage is declared over.
The people most affected are manufacturers, sellers, and distributors who will likely face product redesign, testing, labeling and notification costs, and hospitals and other healthcare providers who buy these products and may see changes in availability or need to switch suppliers or product types. The law limits chemical substitution options, increasing reformulation pressure, but it does not specify enforcement, testing standards for the 0.1% threshold, penalty mechanisms, or how shortage determinations will be made, so there is lingering uncertainty for planning and compliance and no state funding or enforcement agency is identified in the provided text.