SB 804 Pennsylvania Senate · 2025-2026 Regular Session

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

SB 804 amends Pennsylvania's health and safety laws to ban the intentional addition of DEHP and certain ortho-phthalates (like BBP, DBP, DINP) in medical devices. It specifically targets intravenous (IV) solution containers (like IV bags) and IV tubing used in hospitals and healthcare facilities. The bill prohibits manufacturers from adding these chemicals to medical devices if they serve a functional purpose, requiring notice of such additions. This affects device manufacturers and healthcare facilities purchasing these products, directly changing manufacturing standards for common medical equipment.

Bill status passed 3 of 5 stages cleared

Introduction

Jun 2025

Committee Review

Mar 2026

Senate Passage

Mar 2026

House Passage

Governor

Introduced Jun 4, 2025 Last action Mar 24, 2026

Maddy AI version diff · 1 comparison

What changed between versions

Printer's No. PN0902 → Printer's No. PN1282 · 6 edits

MODERATE

The bill was updated to include a new definition for 'Intentionally Added DEHP' and a corresponding prohibition on its use in medical devices starting in 2027. It also added a strict ban on replacing DEHP with other phthalates, set a new threshold for unintentionally added DEHP, and introduced specific exemptions and extensions for manufacturers facing FDA approval delays or equipment limitations.

Scope change

The bill's scope expanded to explicitly define and regulate 'Intentionally Added DEHP' and to prohibit the substitution of DEHP with other ortho-phthalates in new or revised medical devices.

DEFINITION

Added a specific definition for 'Intentionally Added DEHP' to clarify that it refers to DEHP added for a functional or technical effect on the product.

Added a specific definition for 'Unintentionally Added DEHP' to set a maximum allowable quantity of 0.1% weight per weight in containers or tubing.

REQUIREMENT

Added a prohibition against replacing DEHP with another ortho-phthalate in new or revised medical devices.

Added a requirement for manufacturers to notify customers and post notices on their websites regarding delays in meeting the DEHP-free deadline due to FDA approval or equipment issues.

TIMELINE

Added an extension provision allowing manufacturers to delay the 2027 ban on intentionally added DEHP until January 1, 2032, if they meet specific notification and development conditions.

EXEMPTIONS

Added exemptions for human blood collection/storage bags and apheresis/cell therapy blood kits and bags.

Floor votes · Senate Mar 24, 2026

How they voted

48–1

Passed · 1 other

Total votes 50

Mar 24, 2026

D Democratic23

23 Yea

100% Yea

R Republican27

25 Yea 1 Nay 1

92% Yea

Vote distribution

All Yea All Nay Mixed No data

Full legislative history

Actions timeline

Total actions

Key actions

Committee

Amendments

Mar 24, 2026

Committee

Referred to Health

lower

Mar 24, 2026

Upper · Passed

Third consideration and final passage

upper

Mar 23, 2026

Upper · Passed

Re-reported as committed

upper

Nov 12, 2025

Committee

Re-referred to Appropriations

upper

Oct 28, 2025

Upper · Passed

Reported as amended

upper

Jun 4, 2025

Committee

Referred to Institutional Sustainability & Innovation

upper

1 primary · 8 co-sponsors