PENNSYLVANIA, October 28 - 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 -

<--

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

23

24

25

26

27

28

29

30