Pennsylvania SB 1206: 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.

Bill Text

PRIOR PRINTER'S NO. 1554 PRINTER'S NO. 1838
THE GENERAL ASSEMBLY OF PENNSYLVANIA
SENATE BILL
No. 1206
Session of
2026
INTRODUCED BY PENNYCUICK, PHILLIPS-HILL, BOSCOLA, TARTAGLIONE,
FARRY, J. WARD, VOGEL, CAPPELLETTI AND SANTARSIERO,
MARCH 30, 2026
AS AMENDED ON THIRD CONSIDERATION, JUNE 23, 2026
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.
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.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The definition of "virtual manufacturer" in
section 3 of the act of December 14, 1992 (P.L.1116, No.145),
known as the Wholesale Prescription Drug Distributors License
Act, added October 16, 2024 (P.L.988, No.101), is amended to
read:
Section 3. Definitions.
The following words and phrases when used in this act shall
have the meanings given to them in this section unless the
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context clearly indicates otherwise:
* * *
"Virtual manufacturer." A person with a place of business
located in this Commonwealth in the business of manufacturing
and distributing a drug or medical device that:
(1) Holds the drug or device approval and label code or
is otherwise identified on the product label from the United
States Food and Drug Administration[.] or has submitted an
application to the United States Food and Drug Administration
for approval of the drug or device or intends to submit an
application for approval within 12 months.
(2) At no time takes physical possession of any drug or
device in this Commonwealth.
* * *
Section 2. Section 5(a) of the act is amended by adding
paragraphs to read:
Section 5. License application.
(a) Information on application.--An applicant for a license
shall provide the following information on a license application
form approved by the department:
* * *
(6.2) If the applicant is a manufacturer of a
prescription drug that has not been approved by the United
States Food and Drug Administration, a statement that the
applicant has submitted an application to the United States
Food and Drug Administration for approval of the prescription
drug or that the applicant intends to submit an application
for approval within 12 months. The department may not require
approval of a prescription drug by the United States Food and
Drug Administration as a condition of licensure under this
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act.
(6.3) If the applicant is a virtual manufacturer that
does not hold the drug or device approval and label code or
is not otherwise identified on the product label from the
United States Food and Drug Administration, a statement that
the applicant has submitted an application to the United
States Food and Drug Administration for approval of the drug
or device or that the applicant intends to submit an
application for approval within 12 months. The department may
not require approval of a drug or medical device by the
United States Food and Drug Administration as a condition of
licensure under this act.
* * *
Section 3. This act shall take effect in 60 days.
SECTION 1. THE DEFINITION OF "VIRTUAL MANUFACTURER" IN
SECTION 3 OF THE ACT OF DECEMBER 14, 1992 (P.L.1116, NO.145),
KNOWN AS THE WHOLESALE PRESCRIPTION DRUG DISTRIBUTORS LICENSE
ACT, ADDED OCTOBER 16, 2024 (P.L.988, NO.101), IS AMENDED AND
THE SECTION IS AMENDED BY ADDING A DEFINITION TO READ:
SECTION 3. DEFINITIONS.
THE FOLLOWING WORDS AND PHRASES WHEN USED IN THIS ACT SHALL
HAVE THE MEANINGS GIVEN TO THEM IN THIS SECTION UNLESS THE
CONTEXT CLEARLY INDICATES OTHERWISE:
* * *
"TEMPORARY LICENSE." A LICENSE ISSUED BY THE DEPARTMENT TO A
MANUFACTURER OR A VIRTUAL MANUFACTURER UNDER SECTION 5(A.2) FOR
A DRUG OR MEDICAL DEVICE THAT HAS NOT YET RECEIVED FINAL
APPROVAL FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION.
"VIRTUAL MANUFACTURER." A PERSON WITH A PLACE OF BUSINESS
LOCATED IN THIS COMMONWEALTH IN THE BUSINESS OF MANUFACTURING
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AND DISTRIBUTING A DRUG OR MEDICAL DEVICE THAT:
[(1) HOLDS THE DRUG OR DEVICE APPROVAL AND LABEL CODE OR
IS OTHERWISE IDENTIFIED ON THE PRODUCT LABEL FROM THE UNITED
STATES FOOD AND DRUG ADMINISTRATION.]
(1) WITH RESPECT TO THE DRUG OR MEDICAL DEVICE:
(I) HOLDS THE APPLICABLE APPROVAL, CLEARANCE,
AUTHORIZATION OR LABELER CODE ISSUED