An act amending the act of December 14, 1992 (P.L.1116, No.145), entitled "An act providing minimum standards, terms and conditions for the licensing of persons who engage in wholesale distributions in interstate commerce of prescription drugs; and making a repeal," further providing for definitions and for license application.
This bill amends Pennsylvania's Wholesale Prescription Drug Distributors License Act to update definitions and application requirements for drug manufacturers. It clarifies the definition of a "virtual manufacturer" as a company that manufactures and distributes drugs without taking physical possession of the products within the state. The bill requires license applicants to disclose their FDA approval status or intent to submit an application within 12 months, while explicitly stating that FDA approval cannot be made a condition for licensure. These changes affect pharmaceutical companies operating in Pennsylvania and streamline the licensing process for manufacturers at various stages of FDA approval.
Bill status
passed
3 of 5 stages cleared
Introduction
Mar 2026
Committee Review
Jun 2026
Senate Passage
Jun 2026
House Passage
Governor
Introduced Mar 30, 2026
Last action Jun 26, 2026
Maddy AI version diff · 1 comparison
What changed between versions
Printer's No. PN1554
→
Printer's No. PN1838
·
5 edits
MODERATE
This bill update adds a new 'temporary license' category to allow manufacturers and virtual manufacturers to operate in Pennsylvania while waiting for federal drug or device approval. It clarifies that these temporary licenses cannot be used for commercial distribution unless federal law permits it and must expire once the federal application is denied or withdrawn. The changes also refine the definition of a 'virtual manufacturer' to better distinguish between those holding current FDA approval and those with pending applications.
Scope change
The bill now explicitly covers manufacturers and virtual manufacturers operating under a temporary license status, expanding the scope of entities regulated under the Wholesale Prescription Drug Distributors License Act.
DEFINITION
Added a new definition for 'temporary license' to cover drugs or devices awaiting final FDA approval.
REQUIREMENT
Introduced new requirements for temporary licenses, including specific documentation of FDA submission numbers and proof of compliance with federal supply chain rules.
ELIGIBILITY
Refined the definition of 'virtual manufacturer' to include detailed criteria for holding FDA approval versus having a pending application.
ENFORCEMENT
Established that temporary licenses automatically expire if the FDA denies or withdraws the applicant's approval request.
TIMELINE
Set a one-year expiration limit for temporary licenses unless renewed by the department.
Floor votes · Senate Jun 24, 2026
How they voted
50–0
Passed
Total votes 50
Jun 24, 2026
D
Democratic23
100% Yea
R
Republican27
100% Yea
Vote distribution
All Yea
All Nay
Mixed
No data
Full legislative history
Actions timeline
Total actions
9
Key actions
4
Committee
5
Amendments
1
Jun 26, 2026
Committee
Referred to Health
lower
Jun 24, 2026
Upper · Passed
Third consideration and final passage
upper
Jun 23, 2026
Upper · Passed
Amended on third consideration
upper
Jun 22, 2026
Upper · Passed
Re-reported as committed
upper
Jun 10, 2026
Committee
Re-referred to Appropriations
upper
Jun 9, 2026
Upper · Passed
Reported as committed
upper
Mar 30, 2026
Committee
Referred to Institutional Sustainability & Innovation
upper
1 primary · 8 co-sponsors
Sponsors
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