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SECOND REGULAR SESSION
HOUSE BILL NO. 3357
103RD GENERAL ASSEMBL Y
INTRODUCED BY REPRESENT A TIVE DEAN.
7257H.01I JOSEPH ENGLER, Chief Clerk
AN ACT
T o 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 manufactur er has intentionally
4 added to a prod uct and that has a functional or technical effect on the prod uct;
5 (3) "Intravenous solution container", a container used to house medicine, fluid,
6 or nutrition therapy that is intravenously deliver ed to a patient in a hospital, outpatient
7 facility , or other health car e 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 ar e 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);
EXPLANA TION — 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.
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 prod uct that is not used for functional or technical effect on the
25 pr oduct.
26 2. Beginning January 1, 2030, a person or entity shall not sell or distribute into
27 commer ce in this state intravenous solution containers made with intentionally added
28 DEHP .
29 3. Beginning January 1, 2035, a person or entity shall not manufactur e, sell, or
30 distribute into commer ce in this state intravenous tubing made with intentionally added
31 DEHP .
32 4. A person or entity subject to the pr ohibitions in this section shall not repl ace
33 DEHP with another ortho-phthalate in a new or r evised medical device.
34 5. An intravenous solution container or intravenous tubing pr oduct shall not
35 have unintentionally added DEHP present at a quantity at or above one-tenth of one
36 per cent weight per weight.
37 6. The following items, as described in T itle 21 of the Code of Federal
38 Regulations, shall be exempt fr om the req uire ments of this section:
39 (1) Human blood collection and storage bags; and
40 (2) Apher esis and cell therapy blood kits and bags, including integral tubing.
41 7. The date of January 1, 2030, by which compliance is requi red 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 ar e met:
44 (1) The need for an extension is due to pending United States Food and Drug
45 Administration appr oval for the DEHP-free intravenous solution container or due to the
46 manufactur er not having adequate equipment to manufacture the DEHP-fre e
4 7 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 requi rem ents of this section; and
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51 (3) The person or entity pr ovides 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.
✔
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