Pennsylvania HB 2162: An Act amending the act of May 28, 1937 (P.L.955, No.265), referred to as the Housing Authorities Law, further providing for relocation.

Bill Text

PRIOR PRINTER'S NOS. 2805, 3485 PRINTER'S NO. 3680
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No. 2162
Session of
2026
INTRODUCED BY BOROWSKI, FRIEL, KUTZ, VENKAT, MAYES, MERSKI,
PIELLI, HILL-EVANS, PROBST, GUZMAN, BURGOS, SANCHEZ, BRENNAN,
MADDEN, CEPEDA-FREYTIZ, GALLAGHER, BOYD, INGLIS, CURRY,
CIRESI, FLEMING AND SHAFFER, JANUARY 28, 2026
AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES,
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.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. Section 3 of the act of December 14, 1992
(P.L.1116, No.145), known as the Wholesale Prescription Drug
Distributors License Act, is amended by adding a definition to
read:
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.
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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:
* * *
" Conditional TEMPORARY license." A temporary 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
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.
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* * *
Section 2. Section 5 of the act is amended by adding a
subsection to read:
Section 5. License application.
* * *
(a.2) Conditional 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
conditional TEMPORARY license if the applicant submits all of
the 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; o r
(E) A 510(K) PREMARKET NOTIFICATION; OR
(E) (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).
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(2) A conditional 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
conditional TEMPORARY license and may be suspended or
revoked by the depart