SB 804 — An Act amending Title 35 (Health and Safety) of the Pennsylvania Consolidated Statutes, providing for medical devices.

PRIOR PRINTER'S NO.

902 PRINTER'STHE NO.GENERAL ASSEMBLY OF PENNSYLVANIA SENATE BILL Session of No.

1282804 THE2025 GENERALINTRODUCED ASSEMBLYBY OFBOSCOLA, PENNSYLVANIACOLEMAN, SENATEFONTANA, BILLDUSH, SessionCOSTA, KEARNEY, FLYNN, MILLER AND BROWN, JUNE 4, 2025 REFERRED TO INSTITUTIONAL SUSTAINABILITY AND INNOVATION, JUNE 4, 2025 AN ACT AmeConsolidated Statutes, providing for medical devices.a The General Assembly of No.the Commonwealth of Pennsylvania hereby enacts as follows:

804 2025 INTRODUCED BY BOSCOLA, COLEMAN, FONTANA, DUSH, COSTA, KEARNEY, FLYNN, MILLER AND BROWN, JUNE 4, 2025 SENATOR FARRY, INSTITUTIONAL SUSTAINABILITY AND INNOVATION, AS AMENDED, OCTOBER 28, 2025 AN ACT AmeConsolidated Statutes, providing for medical devices.a The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows:

<-- § 58A11.

20250SB0804PN128220250SB0804PN0902 - 2 - (7) DEHP exposure:

The following words and phrases when used in this subchapter 20250SB0804PN128220250SB0804PN0902 - 3 - shall have the meanings given to them in this section unless the context clearly indicates otherwise:

"Health care practitioner." An individual who is authorized <-- to practice some component of the healing arts by a license, permit, certificate or registration issued by a Commonwealth licensing agency or board.

"INTENTIONALLY ADDED DEHP." DEHP THAT A MANUFACTURER HAS <-- INTENTIONALLY ADDED TO A PRODUCT AND THAT HAS A FUNCTIONAL OR TECHNICAL EFFECT ON THE PRODUCT.

(3) Dicyclohexyl phthalate (DCHP) (Chemical Abstracts 20250SB0804PN1282 - 4 - Service Registry Number 84-61-7).

20250SB0804PN0902 - 4 - (5) Diisobutyl phthalate (DIBP) (Chemical Abstracts Service Registry Number 84-69-5).

"Patient." An individual who is under the medical care of a <-- health care practitioner, in addition to the following, as applicable:

"UNINTENTIONALLY ADDED DEHP." DEHP IN AN INTRAVENOUS <-- 20250SB0804PN1282 - 5 - SOLUTION CONTAINER OR INTRAVENOUS TUBING PRODUCT THAT IS NOT USED FOR FUNCTIONAL OR TECHNICAL EFFECT ON THE PRODUCT.

(a) Intravenous solution containers.--Beginning January 1, <--2027, 2027 EXCEPT AS PROVIDED UNDER SUBSECTION (F), BEGINNING JANUARY <-- 1, 2030, a person may not manufacture, sell or distribute intravenous solution containers made with intentionally added 20250SB0804PN0902 - 5 - DEHP.

(b) Intravenous tubing.-- <-- (1) Beginning January 1, 2027, a person may not manufacture, sell or distribute intravenous tubing made with intentionally added DEHP for use in neonatal intensive care units or for the purpose of nutrition infusions or oncology treatment infusions.

(2) The patient's right to request an intravenous solution container or intravenous tubing that is free from 20250SB0804PN1282 - 6 - DEHP and other ortho-phthalates.

(B) INTRAVENOUS TUBING.--BEGINNING JANUARY 1, 2035, A PERSON <-- MAY NOT MANUFACTURE, SELL OR DISTRIBUTE INTRAVENOUS TUBING MADE WITH INTENTIONALLY ADDED DEHP.

(C) REPLACEMENT.--A PERSON MAY NOT REPLACE DEHP WITH ANOTHER ORTHO-PHTHALATE IN A NEW OR REVISED MEDICAL DEVICE.

(D) UNINTENTIONALLY ADDED DEHP.--AN INTRAVENOUS SOLUTION CONTAINER OR INTRAVENOUS TUBING PRODUCT MAY NOT HAVE UNINTENTIONALLY ADDED DEHP PRESENT AT A QUANTITY AT OR ABOVE 0.1% WEIGHT PER WEIGHT (W/W).

(E) EXEMPTIONS.--THE FOLLOWING ITEMS, AS DESCRIBED IN 21 CFR (RELATING TO FOOD AND DRUGS), ARE EXEMPT FROM THE PROVISIONS OF THIS SECTION:

(1) HUMAN BLOOD COLLECTION AND STORAGE BAGS.

(2) APHERESIS AND CELL THERAPY BLOOD KITS AND BAGS, INCLUDING INTEGRAL TUBING.

(F) EXTENSION.--A PERSON, DUE TO PENDING UNITED STATES FOOD AND DRUG ADMINISTRATION APPROVAL FOR THE DEHP-FREE INTRAVENOUS SOLUTION CONTAINER OR DUE TO THE MANUFACTURER NOT HAVING ADEQUATE EQUIPMENT TO MANUFACTURE THE DEHP-FREE INTRAVENOUS SOLUTION CONTAINER, SHALL MEET THE REQUIREMENT UNDER SUBSECTION (A) BY JANUARY 1, 2032, IF ALL OF THE FOLLOWING CONDITIONS ARE MET:

(1) THE PERSON NOTIFIED ITS CUSTOMERS IN THIS COMMONWEALTH, NO LATER THAN JULY 1, 2026, THAT THE PERSON HAS COMMENCED DEVELOPMENT OF THE DEHP-FREE INTRAVENOUS SOLUTION CONTAINER TO MEET THE REQUIREMENTS OF THIS SECTION.

(2) THE PERSON PROVIDES NOTICE TO ITS CUSTOMERS IN THIS COMMONWEALTH AND POSTS TO ITS PUBLICLY ACCESSIBLE INTERNET WEBSITE, NO LATER THAN JANUARY 1, 2028, THAT THE PERSON WILL 20250SB0804PN1282 - 7 - NOT MEET THE DEADLINE IMPOSED UNDER SUBSECTION (A).

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