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.

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28052805, 3485 PRINTER'S NO.

34853680 THE GENERAL ASSEMBLY OF PENNSYLVANIA HOUSE BILL Session of No.

2162 2026 INTRODUCED BY BOROWSKI, FRIEL, KUTZ, VENKAT, MAYES, MERSKI, MADDEN, CEPEDA-FREYTIZ, GALLAGHER, BOYD, INGLIS, CURRY,ENNAN, CIRESICIRESI, FLEMING AND FLEMING,SHAFFER, JANUARY 28, 2026 AS AS AMENDED, JUNE 2,23, 2026ON2026COND HEALTH,CONSIDERATION, 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;

TheSection 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, addedis Octoberamended 16,by 2024adding (P.L.988,a No.101),definition is amended to read:

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:

* * * "Virtual"Conditional manufacturer."TEMPORARY license." A persontemporary withlicense aissued place<-- ofby businessthe <--department locatedto ina thismanufacturer Commonwealthor ina thevirtual businessmanufacturer ofUNDER manufacturingSECTION and5(A.2) distributingfor a drug or medical device that:that has not <-- yet received final approval from the United States Food and Drug Administration.

(1)"VIRTUAL HoldsMANUFACTURER." theA drugPERSON orWITH deviceA approvalPLACE andOF labelBUSINESS code<-- orLOCATED isIN otherwiseTHIS identifiedCOMMONWEALTH onIN theTHE productBUSINESS labelOF fromMANUFACTURING theAND UnitedDISTRIBUTING StatesA FoodDRUG andOR DrugMEDICAL Administration[.]DEVICE orTHAT: 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)[(1) AtHOLDS noTHE timeDRUG takesOR physicalDEVICE possessionAPPROVAL ofAND anyLABEL drugCODE orOR deviceIS inOTHERWISE thisIDENTIFIED Commonwealth.ON THE PRODUCT LABEL FROM THE UNITED STATES FOOD AND DRUG ADMINISTRATION.] (1) WITH RESPECT TO THE DRUG OR MEDICAL DEVICE:

"CONDITIONAL(I) LICENSE."HOLDS ATHE TEMPORARYAPPLICABLE LICENSEAPPROVAL, ISSUEDCLEARANCE, BYAUTHORIZATION THEOR <--LABELER DEPARTMENTCODE TOISSUED ABY MANUFACTURERTHE ORUNITED ASTATES VIRTUALFOOD MANUFACTURERAND FOR A DRUG ADMINISTRATION OR MEDICALIS DEVICEOTHERWISE THATIDENTIFIED HASON NOTLABELING YETAPPROVED, RECEIVEDCLEARED FINALOR APPROVALAUTHORIZED FROMBY THE UNITED STATES FOOD AND DRUG ADMINISTRATION.ADMINISTRATION;

*OR *(II) *FOR SectionPURPOSES 2.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.

Section(2) 5(a)AT ofNO theTIME actTAKES isPHYSICAL amendedPOSSESSION byOF addingANY <--DRUG paragraphsOR toDEVICE read:IN THIS COMMONWEALTH.

20260HB2162PN3680 - 2 - * * * Section 2.

Section 5 of the act is amended by adding a subsection to read:

(a)* Information* on* application.--An(a.2) Conditional TEMPORARY license.-- <-- (1) If the applicant foris a licensemanufacturer shallof providea prescription drug or a virtual manufacturer of a drug or medical device that has not yet received approval from the followingUnited informationStates onFood and Drug Administration, the department may issue a conditional TEMPORARY license applicationif formthe approvedapplicant bysubmits all of <-- the department:following:

*(i) *Documentation *demonstrating (6.2)that Ifan theapplication applicantfor isapproval 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 AdministrationAdministration, forincluding, approvalwhere ofapplicable: the prescription drug or that the applicant intends to submit an application for approval within 12 months.

The(A) department may not require approval of a prescriptionnew drug byapplication thenumber; United States Food and Drug Administration as a condition of licensure under this act.

(6.3)(B) If the applicant is a virtual manufacturer of a drug or medical device and 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 applicationabbreviated tonew the United States Food and Drug Administration for approval of the drug or device or that the applicant intends to submit an application fornumber; approval within 12 months.

The(C) department may not require approval of a drugbiologics orlicense medicalapplication devicenumber; by the United States Food and Drug Administration as a condition of licensure under this act.

*(D) *a *unique SECTIONdevice 2.identification number;

SECTIONor 5<-- OF(E) THE ACT IS AMENDED BY ADDING A <--510(K) SUBSECTIONPREMARKET TONOTIFICATION; READ:

SECTIONOR 5.<-- (E) (F) other documentation acceptable to the <-- department demonstrating active review by the United States Food and Drug Administration.

LICENSE(ii) APPLICATION.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 (A.2)compliance CONDITIONALwith LICENSE.--applicable (1)requirements IFof THE21 APPLICANTU.S.C. 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:

20260HB2162PN3485Ch. - 3 - (I) DOCUMENTATION DEMONSTRATING THAT AN APPLICATION FOR APPROVAL HAS BEEN SUBMITTED TO THE UNITED STATES FOOD AND DRUG ADMINISTRATION, INCLUDING, WHERE APPLICABLE:

(A)9 ASubch. NEW DRUG APPLICATION NUMBER;

(B)V ANPt. ABBREVIATED NEW DRUG APPLICATION NUMBER;

(C)H A(relating BIOLOGICSto LICENSEpharmaceutical APPLICATIONdistribution NUMBER;supply chain).

(D)20260HB2162PN3680 - 3 - (2) A UNIQUEconditional DEVICETEMPORARY IDENTIFICATIONlicense NUMBER;issued under <-- paragraph (1):

OR(i) (E)shall OTHERexpire DOCUMENTATIONone ACCEPTABLEyear TOafter THEissuance DEPARTMENTunless DEMONSTRATINGrenewed ACTIVEby REVIEWthe BYdepartment; THE UNITED STATES FOOD AND DRUG ADMINISTRATION.

(II)(ii) DOCUMENTATIONshall IDENTIFYINGautomatically ANYexpire CONTRACTupon MANUFACTURINGdenial, ORGANIZATIONwithdrawal ORor LICENSEDrefusal MANUFACTURINGof FACILITYthe INVOLVEDapplicant's INapproval THEapplication MANUFACTURE,by PACKAGING,the LABELINGUnited ORStates DISTRIBUTIONFood OFand THEDrug DRUGAdministration; OR MEDICAL DEVICE.

(III)(iii) DOCUMENTATIONmay DEMONSTRATINGnot COMPLIANCEauthorize WITHcommercial APPLICABLEdistribution REQUIREMENTSof OFa 21drug U.S.C.or device unless otherwise permitted under Federal law;

CH.and (iv) does not create a property interest in the conditional TEMPORARY license and may be suspended or <-- revoked by the department for failure to maintain compliance with this act or applicable Federal law.

9(3) SUBCH.An applicant issued a conditional TEMPORARY license <-- under paragraph (1) shall notify the department within five business days of:

V(i) PT.approval, denial, withdrawal or refusal of an application by the United States Food and Drug Administration;

Hor (RELATING(ii) TOany PHARMACEUTICALmaterial DISTRIBUTIONchange SUPPLYto CHAIN).the applicant's manufacturing or distribution arrangements.

(2)(4) AIssuance CONDITIONALof LICENSEa ISSUEDconditional UNDERTEMPORARY PARAGRAPHlicense (1):or a <-- license under this subsection may not be construed as approval, endorsement or authorization of a drug or medical device by the Commonwealth.

(I)(5) SHALLThe EXPIREdepartment ONEmay YEARpromulgate AFTERregulations ISSUANCEand UNLESSdevelop RENEWEDmonitoring, BYreporting THEand DEPARTMENT;enforcement procedures necessary to implement this subsection.

(II)20260HB2162PN3680 SHALL- AUTOMATICALLY4 EXPIRE- UPON(6) DENIAL,Upon WITHDRAWALsatisfactory ORproof REFUSALprovided OFby THEthe APPLICANT'Sconditional APPROVAL<-- APPLICATIONTEMPORARY BYlicensee THEto UNITEDthe STATESdepartment FOODthat ANDall DRUGconditions ADMINISTRATION;for <-- licensure have been met, the department shall convert the conditional TEMPORARY license into a license within 30 days.

(III)<-- MAY(7) NOTTHE AUTHORIZEDEPARTMENT COMMERCIALMAY DISTRIBUTIONNOT OFRENEW A DRUGTEMPORARY ORLICENSE DEVICE<-- UNLESSMORE OTHERWISETHAN PERMITTEDONCE UNDERFOR FEDERALTHE LAW;SAME APPLICANT.