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.

PRIOR PRINTER'S NO.

2805 PRINTER'STHE NO.GENERAL ASSEMBLY OF PENNSYLVANIA HOUSE BILL Session of No.

34852162 THE2026 GENERALINTRODUCED ASSEMBLYBY OFBOROWSKI, PENNSYLVANIAFRIEL, HOUSEKUTZ, BILLVENKAT, SessionMAYES, 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 Amending the act of No.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 prescription drugs;

2162 2026 INTRODUCED BY BOROWSKI, FRIEL, KUTZ, VENKAT, MAYES, MERSKI, MADDEN, CEPEDA-FREYTIZ, GALLAGHER, BOYD, INGLIS, CURRY,ENNAN, CIRESI AND FLEMING, JANUARY 28, 2026 AS AS AMENDED, JUNE 2, 2026ON HEALTH, HOUSE OF REPRESENTATIVES, 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;

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 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:

* * * "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:

"CONDITIONAL LICENSE." A TEMPORARY LICENSE ISSUED BY THE <-- DEPARTMENT TO A MANUFACTURER OR A VIRTUAL MANUFACTURER FOR A DRUG OR MEDICAL DEVICE THAT HAS NOT YET RECEIVED FINAL APPROVAL FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION.

Section 5(a) of the act is amended by adding <-- paragraphs to read:

* * * (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 20260HB2162PN3485 - 2 - 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.

(6.3) If the applicant is a virtual manufacturer of a drug or medical device and does not hold the drug or device 20260HB2162PN2805 - 2 - 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.

* * * SECTION 2.

SECTION 5 OF THE ACT IS AMENDED BY ADDING A <-- SUBSECTION TO READ:

SECTION 5.

LICENSE APPLICATION.

* * * (A.2) CONDITIONAL 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 LICENSE IF THE APPLICANT SUBMITS ALL OF THE FOLLOWING:

20260HB2162PN3485 - 3 - (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;

OR (E) 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 CONDITIONAL 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 LICENSE AND MAY BE SUSPENDED OR REVOKED BY THE DEPARTMENT FOR FAILURE TO MAINTAIN COMPLIANCE WITH 20260HB2162PN3485 - 4 - THIS ACT OR APPLICABLE FEDERAL LAW.

(3) AN APPLICANT ISSUED A CONDITIONAL 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 CONDITIONAL 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 CONDITIONAL LICENSEE TO THE DEPARTMENT THAT ALL CONDITIONS FOR LICENSURE HAVE BEEN MET, THE DEPARTMENT SHALL CONVERT THE CONDITIONAL LICENSE INTO A LICENSE WITHIN 30 DAYS.