Proposal would limit DEHP in IV bags and tubing

The proposal would bar people from making, selling, or distributing IV solution containers with intentionally added DEHP starting January 1, 2030, and IV tubing with intentionally added DEHP starting January 1, 2035. The restrictions cover people who make, sell, or distribute intravenous solution containers or intravenous tubing. The containers hold medicine, fluid, or nutrition given through a vein in a health care facility; the tubing delivers fluids, medicine, or nutrients directly to a person. Blood collection and storage bags, and certain blood kits and bags used for apheresis or cell therapy, would be exempt. For IV containers only, a person could have until January 1, 2032, if pending U.S. Food and Drug Administration approval or inadequate manufacturing equipment prevents meeting the 2030 deadline, and the person gave customers the required notices by July 1, 2026, and January 1, 2028, and posted the later notice online. The container restriction would start January 1, 2030; qualifying people could meet it by January 1, 2032. The tubing restriction would start January 1, 2035.

A person could not replace DEHP with another ortho-phthalate in a new or revised medical device. This restriction would apply when a person makes a new medical device or revises one. Ortho-phthalates are a group of chemicals that includes DEHP and several named alternatives. The act would take effect 90 days after enactment; the proposal gives no separate start date for this restriction.

An IV solution container or IV tubing product could not contain unintentionally added DEHP at or above 0.1% by weight. This limit would cover intravenous solution containers and intravenous tubing products. The proposal defines unintentionally added DEHP as DEHP that has no functional or technical effect on the product. The act would take effect 90 days after enactment; the proposal gives no separate start date for this limit.