HB 2162 — 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.

PRINTER'S NO.     2805

                     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 AND INGLIS,
        JANUARY 28, 2026

     REFERRED TO COMMITTEE ON HEALTH, JANUARY 28, 2026


                                    AN ACT
 1   Amending the act of December 14, 1992 (P.L.1116, No.145),
 2      entitled "An act providing minimum standards, terms and
 3      conditions for the licensing of persons who engage in
 4      wholesale distributions in interstate commerce of
 5      prescription drugs; and making a repeal," further providing
 6      for definitions and for license application.
 7      The General Assembly of the Commonwealth of Pennsylvania
 8   hereby enacts as follows:
 9      Section 1.    The definition of "virtual manufacturer" in
10   section 3 of the act of December 14, 1992 (P.L.1116, No.145),
11   known as the Wholesale Prescription Drug Distributors License
12   Act, added October 16, 2024 (P.L.988, No.101), is amended to
13   read:
14   Section 3.   Definitions.
15      The following words and phrases when used in this act shall
16   have the meanings given to them in this section unless the
17   context clearly indicates otherwise:
18      * * *
19      "Virtual manufacturer."    A person with a place of business
 1   located in this Commonwealth in the business of manufacturing
 2   and distributing a drug or medical device that:
 3             (1)   Holds the drug or device approval and label code or
 4      is otherwise identified on the product label from the United
 5      States Food and Drug Administration[.] or has submitted an
 6      application to the United States Food and Drug Administration
 7      for approval of the drug or device or intends to submit an
 8      application for approval within 12 months.
 9             (2)   At no time takes physical possession of any drug or
10      device in this Commonwealth.
11      * * *
12      Section 2.      Section 5(a) of the act is amended by adding
13   paragraphs to read:
14   Section 5.      License application.
15      (a)    Information on application.--An applicant for a license
16   shall provide the following information on a license application
17   form approved by the department:
18             * * *
19             (6.2)   If the applicant is a manufacturer of a
20      prescription drug that has not been approved by the United
21      States Food and Drug Administration, a statement that the
22      applicant has submitted an application to the United States
23      Food and Drug Administration for approval of the prescription
24      drug or that the applicant intends to submit an application
25      for approval within 12 months. The department may not require
26      approval of a prescription drug by the United States Food and
27      Drug Administration as a condition of licensure under this
28      act.
29             (6.3)   If the applicant is a virtual manufacturer of a
30      drug or medical device and does not hold the drug or device

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 1    approval and label code or is not otherwise identified on the
 2    product label from the United States Food and Drug
 3    Administration, a statement that the applicant has submitted
 4    an application to the United States Food and Drug
 5    Administration for approval of the drug or device or that the
 6    applicant intends to submit an application for approval
 7    within 12 months. The department may not require approval of
 8    a drug or medical device by the United States Food and Drug
 9    Administration as a condition of licensure under this act.
10        * * *
11    Section 3.    This act shall take effect in 60 days.




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