HB 69 — An Act amending the act of May 13, 2008 (P.L.139, No.14), known as the Cancer Drug Repository Program Act, further providing for title and short title of act, for definitions, for establishment, for restocking and dispensing of cancer drugs, for storage, distribution and fees and for immunity; providing for annual report, for list of approved participating pharmacies and for limitations; further providing for regulations; and imposing duties on the State Board of Pharmacy.

PRIOR PRINTER'S NO.

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

132569 THE2025 GENERALINTRODUCED ASSEMBLYBY OFCUTLER, PENNSYLVANIAVENKAT, HOUSEJAMES, BILLNEILSON, SessionRAPP, ofKAUFFMAN, No.CIRESI, MENTZER, GUENST, KUZMA AND PICKETT, JANUARY 14, 2025 REFERRED TO COMMITTEE ON HEALTH, JANUARY 14, 2025 AN ACT Ameact establishing the Cancer Drug Repository Program ford "An accepting donated cancer drugs and dispensing cancer drugs;

69and 2025providing INTRODUCEDfor BYthe CUTLER,powers VENKAT,and JAMES,duties NEILSON,of RAPP,the KAUFFMAN,State KHAN,Board JANUARYof 14,Pharmacy," 2025T,further KUZMA,providing PICKETT,for DEASY,title GILLENand ANDshort AStitle REPORTEDof FROMact, COMMITTEEfor ONdefinitions, HEALTH,for HOUSEestablishment, OFfor REPRESENTATIVES,restocking ASand AMENDED,dispensing APRIL 9, 2025 AN ACT Amending the act of Maycancer 13,drugs, 2008 (P.L.139, No.14), entitled "An act establishing the Cancer Drug Repository Program for acceptingstorage, donateddistribution cancerand drugsfees and dispensingfor cancerimmunity; drugs;

and providing for theannual powersreport and duties of the State Board of Pharmacy," further providing for title and short title of act, for definitions, for establishment, for restocking and dispensing of cancer drugs, for storage, distribution and list of approved participating pharmacies;

further providing forPharmacy.ations; regulations;

and imposing duties on the State Board of Pharmacy.The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows:

The General Assembly of the Commonwealth of Pennsylvania hereby enacts as follows:

"Health care facility." [A for-profit or nonprofit entity providing clinically related health services, including those operated by the Commonwealth or its political subdivisions and including a general or special hospital, including psychiatric 20250HB0069PN1325 - 2 - hospitals, rehabilitation hospitals, ambulatory surgical 20250HB0069PN0057 - 2 - facilities, long-term care nursing facilities, a hospice, a cancer treatment center using radiation therapy on an ambulatory basis and an inpatient drug and alcohol treatment facility.] As defined in section 802.1 of the act of July 19, 1979 (P.L.130, No.48), known as the Health Care Facilities Act.

["Unit dose system." A system wherein all individually sealed unit doses are physically connected as a unit.] 20250HB0069PN1325 - 3 - "Wholesale distributor of prescription drugs." As defined in 20250HB0069PN0057 - 3 - section 3 of the act of December 14, 1992 (P.L.1116, No.145), known as the Wholesale Prescription Drug Distributors License Act.

(2) The [cancer] prescription drug may not be accepted or dispensed by the approved participating pharmacy if the [cancer] prescription drug bears an expiration date that is 20250HB0069PN1325 - 4 - earlier than six months after the date the [cancer] 20250HB0069PN0057 - 4 - prescription drug was restocked or the [cancer] prescription drug is adulterated or misbranded.

(b) Handling fee.--An approved participating pharmacy may charge a handling fee for distributing or dispensing [cancer] 20250HB0069PN1325 - 5 - prescription drugs under the program.

The fee shall be 20250HB0069PN0057 - 5 - established in regulations promulgated by the board.

[ImmunityImmunity granted under this <-- section is solely applicable to the donation, acceptance, distribution, dispensing or manufacture of the actual medications donated to the program and is explicitly not a general waiver of liability.]liability. THE IMMUNITY PROVIDED UNDER THIS <-- SECTION SHALL NOT EXTEND TO THE DONATION, ACCEPTANCE, DISTRIBUTION, DISPENSING OR MANUFACTURE OF THE PRESCRIPTION DRUGS DONATED TO THE PROGRAM IF ANY OF THE FOLLOWING APPLY:

(1) DAMAGES RESULT FROM THE GROSS NEGLIGENCE, RECKLESSNESS OR INTENTIONAL MISCONDUCT OF THE DONOR.

(2) THE DONOR HAS, OR SHOULD HAVE, ACTUAL OR CONSTRUCTIVE KNOWLEDGE THAT THE PRESCRIPTION DRUGS ARE TAINTED, CONTAMINATED OR HARMFUL TO THE HEALTH OR WELL-BEING OF PATIENTS PARTICIPATING IN THE PROGRAM.

(a) Report.--The board shall report annually by December 31 of each year on the progress in implementing and administering 20250HB0069PN1325 - 6 - this act and submit the report to all of the following:

(4) The chairperson and minority chairperson of the Professional Licensure Committee of the House of 20250HB0069PN0057 - 6 - Representatives.

The board shall update the list under 20250HB0069PN1325 - 7 - this section within 30 days of a change in the list and note the change from the previous list on the board's publicly accessible Internet website.

The regulations shall include:] (a) Authority.--In order to facilitate the prompt implementation of this act, the board shall promulgate temporary 20250HB0069PN0057 - 7 - regulations that shall expire no later than two THREE years <-- following the publication of the temporary regulations.

(1) Income eligibility criteria and other standards and 20250HB0069PN1325 - 8 - procedures for individuals participating in the program, determined by the Department of [Public Welfare] Human Services in conjunction with the board.

20250HB0069PN0057 - 8 - (4) The maximum handling fee that may be charged by entities permitted to restock and distribute or dispense donated [cancer] prescription drugs.

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