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.

PRIOR PRINTER'S NO.

1554 PRINTER'STHE NO.GENERAL ASSEMBLY OF PENNSYLVANIA SENATE BILL Session of No.

1838 THE GENERAL ASSEMBLY OF PENNSYLVANIA SENATE BILL Session of No.

WARD, VOGEL,VOGEL CAPPELLETTI AND SANTARSIERO,CAPPELLETTI, MARCH 30, 2026 ASREFERRED AMENDEDTO ONINSTITUTIONAL THIRDSUSTAINABILITY CONSIDERATION,AND JUNEINNOVATION, 23,MARCH 30, 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 prescriptionwholesale drugs;distributions in interstate commerce of for definitions and for license application.rther providing The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows:

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:

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:

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 20260SB1206PN1838 - 2 - act.

(6.3) If the applicant is a virtual manufacturer that does not hold the drug or device approval and label code or 20260SB1206PN1554 - 2 - 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.

SECTION20260SB1206PN1554 1.- 3 -

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 20260SB1206PN1838 - 3 - 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 20260SB1206PN1838 - 4 - 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).