HB 2162 Pennsylvania House · 2025-2026 Regular Session

An Act amending the act of December 14, 1992 (P.L.1116, No.145), known as the Wholesale Prescription Drug Distributors License Act, further providing for definitions and for license application.

HB 2162 amends Pennsylvania's Wholesale Prescription Drug Distributors License Act to clarify definitions and license application requirements. It specifically defines "virtual manufacturer" as a business that doesn't physically handle drugs in Pennsylvania but has FDA approval processes underway, including submitting or planning to submit FDA applications within 12 months. The bill adds new application requirements: manufacturers of unapproved drugs must state they've applied to or plan to apply to the FDA within 12 months, and virtual manufacturers must provide similar documentation. Crucially, it states the state department cannot require FDA approval as a condition for licensure. This directly affects drug distributors operating under the "virtual manufacturer" model and unapproved drug manufacturers seeking state licenses.
Bill status passed 3 of 5 stages cleared
Introduction
Jan 2026
Committee Review
Jun 2026
House Passage
Jun 2026
Senate Passage
Governor
Introduced Jan 28, 2026 Last action Jun 25, 2026
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What changed between versions

Printer's No. PN3485 Printer's No. PN3680 · 5 edits
MODERATE
This bill updates the definition of a 'virtual manufacturer' to clarify that they must hold FDA approval or have a pending application for their products. It also introduces a new 'conditional temporary license' for manufacturers of drugs that are not yet fully approved by the FDA, requiring specific documentation to prove the product is under active review. The changes aim to streamline licensing for emerging medical technologies while ensuring patient safety through stricter reporting and compliance requirements.
Scope change
The bill expands the scope of the Wholesale Prescription Drug Distributors License Act to explicitly include conditional licensing for products awaiting FDA approval, previously not clearly defined.
DEFINITION

The definition of 'virtual manufacturer' was updated to specify that the entity must hold an FDA approval, clearance, or authorization code, or have a pending application for the specific drug or device.

The term 'Conditional License' was renamed and redefined as 'Conditional Temporary License' to reflect its status as a temporary measure for unapproved products.

REQUIREMENT

A new 'conditional temporary license' was created for manufacturers of drugs or devices that have not yet received final FDA approval, requiring submission of specific application numbers or proof of active FDA review.

New requirements mandate that licensees notify the department within five business days of FDA approval status changes or material changes to their manufacturing arrangements.

ENFORCEMENT

The bill adds a limit stating that a temporary license may not be renewed more than once for the same applicant.

Floor votes · House Jun 23, 2026

How they voted

2010
Passed
Total votes 201
Jun 23, 2026
D Democratic102
102 Yea
100% Yea
R Republican99
99 Yea
100% Yea
Vote distribution
All Yea All Nay Mixed No data
Full legislative history

Actions timeline

Total actions
11
Key actions
5
Committee
6
Amendments
1
Jun 25, 2026
Committee
Referred to Institutional Sustainability & Innovation
upper
Jun 24, 2026
Lower · Passed
Third consideration and final passage
lower
Jun 24, 2026
Lower · Passed
Re-reported as committed
lower
Jun 23, 2026
House · Passed
House Vote: pass (201-0)
house
Jun 23, 2026
Committee
Re-committed to Appropriations
lower
Jun 23, 2026
Lower · Passed
Re-reported as committed
lower
Jun 2, 2026
Committee
Re-committed to Rules
lower
Jun 2, 2026
Lower · Passed
Reported as amended
lower
Jan 28, 2026
Committee
Referred to Health
lower
1 primary · 24 co-sponsors

Sponsors