HOUSE BILL NO. 3357 103RD GENERAL ASSEMBLY
INTRODUCED BY REPRESENTATIVE DEAN.
7257H.01I JOSEPH ENGLER, Chief Clerk
AN ACT To amend chapter 191, RSMo, by adding thereto one new section relating to the safety of medical devices.
Be it enacted by the General Assembly of the state of Missouri, as follows:
Section A. Chapter 191, RSMo, is amended by adding thereto one new section, to be 2 known as section 191.647, to read as follows: 191.647. 1. As used in this section, the following terms mean: 2 (1) "DEHP", di(2-ethylhexyl) phthalate; 3 (2) "Intentionally added DEHP", DEHP that a manufacturer has intentionally 4 added to a product and that has a functional or technical effect on the product; 5 (3) "Intravenous solution container", a container used to house medicine, fluid, 6 or nutrition therapy that is intravenously delivered to a patient in a hospital, outpatient 7 facility, or other health care facility; 8 (4) "Intravenous tubing", tubing used to intravenously administer fluids, 9 medication, or nutrients directly to an adult, child, or infant; 10 (5) "Ortho-phthalate", a class of chemicals that are esters of ortho-phthalic acid, 11 including DEHP or any of the following: 12 (a) Benzyl butyl phthalate (BBP); 13 (b) Dibutyl phthalate (DBP); 14 (c) Dicyclohexyl phthalate (DCHP); 15 (d) Diethyl phthalate (DEP); 16 (e) Diisobutyl phthalate (DIBP); 17 (f) Diisodecyl phthalate (DIDP);
EXPLANATION — Matter enclosed in bold-faced brackets [thus] in the above bill is not enacted and is intended to be omitted from the law. Matter in bold-face type in the above bill is proposed language. HB 3357 2
18 (g) Diisononyl phthalate (DINP); 19 (h) Di-n-hexyl phthalate (DnHP); 20 (i) Di-n-octyl phthalate (DNOP); 21 (j) Di-n-pentyl phthalate (DnPP); or 22 (k) Diisoheptyl phthalate (DIHP); 23 (6) "Unintentionally added DEHP", DEHP in an intravenous solution container 24 or intravenous tubing product that is not used for functional or technical effect on the 25 product. 26 2. Beginning January 1, 2030, a person or entity shall not sell or distribute into 27 commerce in this state intravenous solution containers made with intentionally added 28 DEHP. 29 3. Beginning January 1, 2035, a person or entity shall not manufacture, sell, or 30 distribute into commerce in this state intravenous tubing made with intentionally added 31 DEHP. 32 4. A person or entity subject to the prohibitions in this section shall not replace 33 DEHP with another ortho-phthalate in a new or revised medical device. 34 5. An intravenous solution container or intravenous tubing product shall not 35 have unintentionally added DEHP present at a quantity at or above one-tenth of one 36 percent weight per weight. 37 6. The following items, as described in Title 21 of the Code of Federal 38 Regulations, shall be exempt from the requirements of this section: 39 (1) Human blood collection and storage bags; and 40 (2) Apheresis and cell therapy blood kits and bags, including integral tubing. 41 7. The date of January 1, 2030, by which compliance is required for a person or 42 entity under subsection 2 of this section shall be extended to January 1, 2032, if all of the 43 following conditions are met: 44 (1) The need for an extension is due to pending United States Food and Drug 45 Administration approval for the DEHP-free intravenous solution container or due to the 46 manufacturer not having adequate equipment to manufacture the DEHP-free 47 intravenous solution container; 48 (2) The person or entity notified its Missouri customers, before October 1, 2026, 49 that it has commenced development of the DEHP-free intravenous solution container to 50 meet the requirements of this section; and HB 3357 3
51 (3) The person or entity provides notice to its customers and posts to its official 52 internet website, before January 1, 2028, that it will not meet the deadline imposed 53 under subsection 2 of this section. ✔
Statutes affected: