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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 BY THE UNITED STATES
FOOD AND DRUG ADMINISTRATION OR IS OTHERWISE IDENTIFIED
ON LABELING APPROVED, CLEARED OR AUTHORIZED BY THE UNITED
STATES FOOD AND DRUG ADMINISTRATION; OR
(II) FOR PURPOSES OF A TEMPORARY LICENSE, HAS
SUBMITTED TO THE UNITED STATES FOOD AND DRUG
ADMINISTRATION AND HAS PENDING BEFORE THE UNITED STATES
FOOD AND DRUG ADMINISTRATION AN APPLICATION, PREMARKET
NOTIFICATION, REQUEST OR OTHER SUBMISSION SEEKING
APPROVAL, CLEARANCE OR AUTHORIZATION FOR THE DRUG OR
MEDICAL DEVICE.
(2) AT NO TIME TAKES PHYSICAL POSSESSION OF ANY DRUG OR
DEVICE IN THIS COMMONWEALTH.
* * *
SECTION 2. SECTION 5 OF THE ACT IS AMENDED BY ADDING A
SUBSECTION TO READ:
SECTION 5. LICENSE APPLICATION.
* * *
(A.2) TEMPORARY LICENSE.--
(1) IF THE APPLICANT IS A MANUFACTURER OF A PRESCRIPTION
DRUG OR A VIRTUAL MANUFACTURER OF A DRUG OR MEDICAL DEVICE
THAT HAS NOT YET RECEIVED APPROVAL FROM THE UNITED STATES
FOOD AND DRUG ADMINISTRATION, THE DEPARTMENT MAY ISSUE A
TEMPORARY LICENSE IF THE APPLICANT SUBMITS ALL OF THE
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FOLLOWING:
(I) DOCUMENTATION DEMONSTRATING THAT AN APPLICATION
FOR APPROVAL HAS BEEN SUBMITTED TO THE UNITED STATES FOOD
AND DRUG ADMINISTRATION, INCLUDING, WHERE APPLICABLE:
(A) A NEW DRUG APPLICATION NUMBER;
(B) AN ABBREVIATED NEW DRUG APPLICATION NUMBER;
(C) A BIOLOGICS LICENSE APPLICATION NUMBER;
(D) A UNIQUE DEVICE IDENTIFICATION NUMBER;
(E) A 510(K) PREMARKET NOTIFICATION; OR
(F) OTHER DOCUMENTATION ACCEPTABLE TO THE
DEPARTMENT DEMONSTRATING ACTIVE REVIEW BY THE UNITED
STATES FOOD AND DRUG ADMINISTRATION.
(II) DOCUMENTATION IDENTIFYING ANY CONTRACT
MANUFACTURING ORGANIZATION OR LICENSED MANUFACTURING
FACILITY INVOLVED IN THE MANUFACTURE, PACKAGING, LABELING
OR DISTRIBUTION OF THE DRUG OR MEDICAL DEVICE.
(III) DOCUMENTATION DEMONSTRATING COMPLIANCE WITH
APPLICABLE REQUIREMENTS OF 21 U.S.C. CH. 9 SUBCH. V PT. H
(RELATING TO PHARMACEUTICAL DISTRIBUTION SUPPLY CHAIN).
(2) A TEMPORARY LICENSE ISSUED UNDER PARAGRAPH (1):
(I) SHALL EXPIRE ONE YEAR AFTER ISSUANCE UNLESS
RENEWED BY THE DEPARTMENT;
(II) SHALL AUTOMATICALLY EXPIRE UPON DENIAL,
WITHDRAWAL OR REFUSAL OF THE APPLICANT'S APPROVAL
APPLICATION BY THE UNITED STATES FOOD AND DRUG
ADMINISTRATION;
(III) MAY NOT AUTHORIZE COMMERCIAL DISTRIBUTION OF A
DRUG OR DEVICE UNLESS OTHERWISE PERMITTED UNDER FEDERAL
LAW; AND
(IV) DOES NOT CREATE A PROPERTY INTEREST IN THE
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TEMPORARY LICENSE AND MAY BE SUSPENDED OR REVOKED BY THE
DEPARTMENT FOR FAILURE TO MAINTAIN COMPLIANCE WITH THIS
ACT OR APPLICABLE FEDERAL LAW.
(3) AN APPLICANT ISSUED A TEMPORARY LICENSE UNDER
PARAGRAPH (1) SHALL NOTIFY THE DEPARTMENT WITHIN FIVE
BUSINESS DAYS OF:
(I) APPROVAL, DENIAL, WITHDRAWAL OR REFUSAL OF AN
APPLICATION BY THE UNITED STATES FOOD AND DRUG
ADMINISTRATION; OR
(II) ANY MATERIAL CHANGE TO THE APPLICANT'S
MANUFACTURING OR DISTRIBUTION ARRANGEMENTS.
(4) ISSUANCE OF A TEMPORARY LICENSE OR A LICENSE UNDER
THIS SUBSECTION MAY NOT BE CONSTRUED AS APPROVAL, ENDORSEMENT
OR AUTHORIZATION OF A DRUG OR MEDICAL DEVICE BY THE
COMMONWEALTH.
(5) THE DEPARTMENT MAY PROMULGATE REGULATIONS AND
DEVELOP MONITORING, REPORTING AND ENFORCEMENT PROCEDURES
NECESSARY TO IMPLEMENT THIS SUBSECTION.
(6) UPON SATISFACTORY PROOF PROVIDED BY THE TEMPORARY
LICENSEE TO THE DEPARTMENT THAT ALL CONDITIONS FOR LICENSURE
HAVE BEEN MET, THE DEPARTMENT SHALL CONVERT THE TEMPORARY
LICENSE INTO A LICENSE WITHIN 30 DAYS.
(7) THE DEPARTMENT MAY NOT RENEW A TEMPORARY LICENSE
MORE THAN ONCE FOR THE SAME APPLICANT.
* * *
SECTION 3. THIS ACT SHALL TAKE EFFECT IN 60 DAYS.
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