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PRIOR PRINTER'S NOS. 57, 1325 PRINTER'S NO. 3487
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No. 69
Session of
2025
INTRODUCED BY CUTLER, VENKAT, JAMES, NEILSON, RAPP, KAUFFMAN,
CIRESI, MENTZER, GUENST, KUZMA, PICKETT, DEASY, GILLEN, KHAN,
FRANKEL AND SHAFFER, JANUARY 14, 2025
AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES,
JUNE 2, 2026
AN ACT
Amending the act of May 13, 2008 (P.L.139, No.14), entitled "An
act establishing the Cancer Drug Repository Program for
accepting donated cancer drugs and dispensing cancer drugs;
and providing for the powers 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
fees and for immunity; providing for annual report and, for
list of approved participating pharmacies AND FOR
LIMITATIONS; further providing for regulations; and imposing
duties on the State Board of Pharmacy.
The General Assembly of the Commonwealth of Pennsylvania
hereby enacts as follows:
Section 1. The title and sections 1, 2, 3, 4, 5(a) and (b)
and 6 of the act of May 14, 2008 (P.L.139, No.14), known as the
Cancer Drug Repository Program Act, are amended to read:
SECTION 1. THE TITLE AND SECTIONS 1, 2, 3 AND 4 OF THE ACT
OF MAY 13, 2008 (P.L.139, NO.14), KNOWN AS THE CANCER DRUG
REPOSITORY PROGRAM ACT, ARE AMENDED TO READ:
AN ACT
Establishing the [Cancer] Prescription Drug Repository Program
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for accepting donated [cancer] prescription drugs and
dispensing [cancer] prescription drugs; and providing for the
powers and duties of the State Board of Pharmacy.
Section 1. Short title.
This act shall be known and may be cited as the [Cancer]
Prescription Drug Repository Program Act.
Section 2. 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:
"Adulterated." As specified under section 7 of the act of
April 14, 1972 (P.L.233, No.64), known as The Controlled
Substance, Drug, Device and Cosmetic Act.
"Approved participating pharmacy." A pharmacy approved by
the State Board of Pharmacy for the purpose of dispensing unused
[cancer] prescription drugs to participating entities and to
patients who are indigent.
"Board." The State Board of Pharmacy of the Commonwealth.
"Cancer drug." A prescription drug used to treat any of the
following:
(1) Cancer or its side effects.
(2) The side effects of a prescription drug used to
treat cancer or its side effects.
["Closed drug delivery system." A system in which the actual
control of a unit dose medication is maintained by a health care
facility, health clinic, hospital, pharmacy or physician's
office rather than an individual patient.]
"Controlled substance." As defined in section 2 of The
Controlled Substance, Drug, Device and Cosmetic Act.
"Health care facility." [A for-profit or nonprofit entity
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providing clinically related health services, including those
operated by the Commonwealth or its political subdivisions and
including a general or special hospital, including psychiatric
hospitals, rehabilitation hospitals, ambulatory surgical
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.
"Health clinic." A for-profit or nonprofit clinic providing
health services.
"Hospital." An entity licensed as a hospital under the [act
of July 19, 1979 (P.L.130, No.48), known as the] Health Care
Facilities Act.
"INDIGENT." AN INDIVIDUAL WHO LACKS SUFFICIENT FINANCIAL
RESOURCES TO OBTAIN PRESCRIPTION MEDICATIONS, INCLUDING AN
INDIVIDUAL WHO IS UNINSURED, UNDERINSURED, ENROLLED IN A PUBLIC
ASSISTANCE HEALTH BENEFITS PROGRAM OR WHOSE HOUSEHOLD INCOME
DOES NOT EXCEED A THRESHOLD ESTABLISHED BY THE BOARD THROUGH
REGULATION.
"Manufacturer." As defined in section 2 of The Controlled
Substance, Drug, Device and Cosmetic Act.
"Misbranded." As specified under section 8 of The Controlled
Substance, Drug, Device and Cosmetic Act.
"Pharmacist." A pharmacist licensed by the Commonwealth.
"Pharmacy." A pharmacy licensed by the Commonwealth.
"PHARMACY BENEFITS MANAGER." AN ENTITY THAT PERFORMS
PHARMACY BENEFITS MANAGEMENT AS DEFINED IN SECTION 103 OF THE
ACT OF NOVEMBER 21, 2016 (P.L.1318, NO.169), KNOWN AS THE
PHARMACY AUDIT INTEGRITY AND TRANSPARENCY ACT.
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"Physician's office." The office of a person licensed to
practice medicine and surgery or osteopathic medicine and
surgery.
"Prescribing practitioner." A health care practitioner
licensed under the laws of this Commonwealth who is authorized
to prescribe [cancer] prescription drugs.
"Prescription drug." A drug requiring a prescription in this
Commonwealth. The term includes cancer drugs. The term does not
include a controlled substance.
"Program." The [Cancer] Prescription Drug Repository Program
established in section 3.
["Unit dose system." A system wherein all individually
sealed unit doses are physically connected as a unit.]
"REVERSE DISTRIBUTOR." A PERSON LICENSED OR REGISTERED TO
RECEIVE PRESCRIPTION DRUGS FOR THE PURPOSE OF RETURNING,
PROCESSING OR DESTROYING THE PRESCRIPTION DRUGS IN ACCORDANCE
WITH FEDERAL AND STATE LAW.
"THIRD-PARTY LOGISTICS PROVIDER." AN ENTITY THAT PROVIDES OR
COORDINATES WAREHOUSING OR OTHER LOGISTICS SERVICES FOR A
PRODUCT ON BEHALF OF A MANUFACTURER, WHOLESALE DISTRIBUTOR OR
DISPENSER BUT DOES NOT TAKE OWNERSHIP OF THE PRODUCT OR HAVE
RESPONSIBILITY TO DIRECT THE SALE OR DISPOSITION OF THE PRODUCT.
"UNDERINSURED." AN INDIVIDUAL WHO HAS HEALTH INSURANCE
COVERAGE BUT WHOSE INSURANCE DOES NOT ADEQUATELY COVER THE COST
OF A PRESCRIPTION DRUG, INCLUDING DUE TO COPAYMENTS,
COINSURANCE, DEDUCTIBLES, FORMULARY RESTRICTIONS OR COVERAGE
LIMITATIONS, RESULTING IN FINANCIAL DIFFICULTY OBTAINING THE
PRESCRIPTION DRUG.
"UNINSURED." AN INDIVIDUAL WHO DOES NOT HAVE HEALTH
INSURANCE COVERAGE THAT PROVIDES PRESCRIPTION DRUG BENEFITS.
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"Wholesale distributor of prescription drugs." As defined in
section 3 of the act of December 14, 1992 (P.L.1116, No.145),
known as the Wholesale Prescription Drug Distributors License
Act.
Section 3. Establishment.
(A) DUTY OF BOARD.--The board shall establish a [Cancer]
Prescription Drug Repository Program consistent with public
health and safety standards through which unused [cancer]
prescription drugs may be redispensed to [cancer] patients by
pharmacies approved by the board for the purpose of dispensing
unused [cancer] prescription drugs to residents who are
indigent. The board shall develop and promulgate rules and
regulations to establish procedures necessary to implement the
program. Participation PROGRAM.
(B) PARTICIPATION.--PARTICIPATION in the program shall be
voluntary.
Section 4. Restocking and dispensing of [cancer] prescription
drugs.
An [entity that is part of a closed drug delivery system]
individual, health care facility, hospital , health clinic ,
manufacturer or , wholesale distributor of prescription drugs ,
REVERSE DISTRIBUTOR, THIRD-PARTY LOGISTICS PROVIDER, PHARMACY
BENEFITS MANAGER OR OTHER ENTITY APPROVED BY THE BOARD BY
REGULATION may return or donate to an approved participating
pharmacy an unused [cancer] prescription drug under the
following conditions:
(1) [If the cancer] The prescription drug is in its
original unopened, sealed and tamper-evident [unit dose]
packaging. A [cancer] prescription drug packaged in single-
unit doses may be accepted and dispensed if the outside
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packaging is opened but the single-unit-dose packaging is
unopened.
(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
earlier than six months after the date the [cancer]
prescription drug was restocked or the [cancer] prescription
drug is adulterated or misbranded.
[(3) Except as provided in this subsection, an unused
cancer drug dispensed under a State medical assistance
program may be accepted and dispensed by the approved
participating pharmacy.
(4) In the case of controlled substances, as it is
allowed by Federal law.]
(5) Subject to this act and except as otherwise
prohibited by Federal or State law, an unused prescription
drug dispensed under a State medical assistance program may
be accepted and dispensed by an approved participating
pharmacy.
SECTION 2. SECTION 5(A) AND (B) OF THE ACT ARE AMENDED AND
THE SECTION IS AMENDED BY ADDING SUBSECTIONS TO READ:
Section 5. Storage, distribution and fees.
(a) General rule.--An approved participating pharmacy that
accepts donated [cancer] prescription drugs under the [Cancer]
Prescription Drug Repository Program shall comply with all
applicable provisions of Federal and State law [relating to],
including the storage, distribution and dispensing of [cancer]
prescription drugs and shall inspect all [cancer] prescription
drugs prior to dispensing to determine if they are adulterated
or misbranded. The [cancer] prescription drugs shall only be
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dispensed by a pharmacist according to State law pursuant to a
prescription issued by a prescribing practitioner. The [cancer]
prescription drugs may be distributed to another participating
physician's office, pharmacy, hospital or health clinic for
dispensing by a pharmacist as allowed by Federal or State law.
(b) Handling fee.--An approved participating pharmacy may
charge a handling fee for distributing or dispensing [cancer]
prescription drugs under the program. The fee shall be
established in regulations promulgated by the board. [Cancer]
Prescription drugs donated under the program shall not be
resold.] NOTHING IN THIS SECTION SHALL BE CONSTRUED TO AUTHORIZE
A PARTICIPATING PHARMACY OR OTHER ENTITY TO RESELL A DONATED
PRESCRIPTION DRUG.
* * *
(E) DRUG SUPPLY CHAIN SECURITY.--A DONATED PRESCRIPTION DRUG
SHALL COMPLY WITH APPLICABLE FEDERAL AND STATE DRUG SUPPLY CHAIN
SECURITY REQUIREMENTS, INCLUDING 21 U.S.C. CH. 9 SUBCH. V. PT. H
(RELATING TO PHARMACEUTICAL DISTRIBUTION SUPPLY CHAIN).
(F) ELECTRONIC SYSTEM REQUIREMENTS.--A DONATED PRESCRIPTION
DRUG SHALL COMPLY WITH APPLICABLE ELECTRONIC SYSTEM REQUIREMENTS
CAPABLE OF MAINTAINING A CONTINUOUS CHAIN OF CUSTODY AND
AUDITABLE RECORD FOR EACH DONATED PRESCRIPTION DRUG IN
COMPLIANCE WITH FEDERAL AND STATE LAW, INCLUDING 21 U.S.C. CH. 9
SUBCH. V. PT. H. RECORDS REQUIRED UNDER THIS SUBSECTION SHALL BE
MAINTAINED FOR A PERIOD DETERMINED BY THE BOARD AND SHALL BE
MADE AVAILABLE TO THE BOARD UPON REQUEST.
SECTION 3. SECTION 6 OF THE ACT IS AMENDED TO READ:
Section 6. Immunity.
Any person or entity, acting in good faith, who exercises
reasonable care in donating, accepting, distributing, dispensing
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or manufacturing [cancer] prescription drugs donated and
utilized under the program shall be immune from civil or
criminal liability or professional disciplinary action for any
injury, death or loss to a person or property relating to
activities under the [program. [Immunity 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.] PROGRAM, INCLUDING LIABILITY FOR
FAILURE TO TRANSFER OR COMMUNICATE PRODUCT OR CONSUMER INFO OF
THE EXPIRATION DATE OF THE DONATED PRESCRIPTION DRUG. The
immunity provided under this section shall not extend to the
donation, acceptance, distribution, dispensing or manufacture of
the prescription drugs donated PERSON THAT DONATED THE
PRESCRIPTION DRUGS 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.
Section 2 4. The act is amended by adding sections to read:
Section 6.1. Annual report.
(a) Report.--The board shall report annually by December 31
of each year on the progress in implementing and administering
this act and submit the report to all of the following:
(1) The chairperson and minority chairperson of the
Health and Human Services Committee of the Senate.
(2) The chairperson and minority chairperson of the
Health Committee of the House of Representatives.
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(3) The chairperson and minority chairperson of the
Consumer Protection and Professional Licensure Committee of
the Senate.
(4) The chairperson and minority chairperson of the
Professional Licensure Committee of the House of
Representatives.
(b) Contents.--A report under subsection (a) shall include
all of the following information:
(1) The name and address of each approved participating
pharmacy in the program.
(2) The number of approved participating pharmacies in
the program by county.
(3) The number of approved participating pharmacies that
have withdrawn from the program.
(4) The number of pharmacies that the board has refused
to approve, has revoked or has suspended from participating
in the program.
(5) THE QUANTITY AND ESTIMATED VALUE OF PRESCRIPTION
DRUGS REDISTRIBUTED UNDER THE PROGRAM.
(5) (6) Recommendations to the General Assembly for
improvements or changes to the program as the board deems
necessary.
Section 6.2. List of approved participating pharmacies.
The board shall post on the board's publicly accessible
Internet website a list of each approved participating pharmacy,
including the address and telephone number of each approved
participating pharmacy. The board shall update the list under
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.
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SECTION 6.3. LIMITATIONS.
NOTWITHSTANDING ANY OTHER PROVISION OF THIS ACT:
(1) A CONTROLLED SUBSTANCE MAY NOT BE ACCEPTED, DONATED,
DISPENSED, TRANSFERRED, DISTRIBUTED OR REDISTRIBUTED AS PART
OF THE PROGRAM.
(2) A PRESCRIPTION DRUG THAT REQUIRES THE PRESCRIPTION
DRUG BE DISPENSED TO A PATIENT REGISTERED WITH THE DRUG'S
MANUFACTURER IN ACCORDANCE WITH FEDERAL FOOD AND DRUG
ADMINISTRATION REQUIREMENTS MAY NOT BE ACCEPTED, DONATED,
DISPENSED, TRANSFERRED, DISTRIBUTED OR REDISTRIBUTED AS PART
OF THE PROGRAM.
Section 3 5. Section 7 of the act is amended to read:
Section 7. Regulations.
[The board shall promulgate regulations to carry out the
purposes of this act within 90 days of the effective date of
this section. The regulations shall include:]
(a) Authority.--In order to facilitate the prompt
implementation of this act, the board shall promulgate temporary
regulations NO LATER THAN DECEMBER 31, 2027, that shall expire
no later than three years following the publication of the
temporary regulations. The board may promulgate temporary
regulations not subject to:
(1) Section 612 of the act of April 9, 1929 (P.L.177,
No.175), known as The Administrative Code of 1929.
(2) Sections 201, 202, 203, 204 and 205 of the act of
July 31, 1968 (P.L.769, No.240), referred to as the
Commonwealth Documents Law.
(3) Sections 204(b) and 301(10) of the act of October
15, 1980 (P.L.950, No.164), known as the Commonwealth
Attorneys Act.
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(4) The act of June 25, 1982 (P.L.633, No.181), known as
the Regulatory Review Act.
(b) Expiration.--The board's authority to adopt temporary
regulations under subsection (a) shall expire two years after
the effective date of this subsection DECEMBER 31, 2027 .
Regulations adopted after this period shall be promulgated as
provided by law before the expiration of the temporary
regulations under subsection (a).
(c) Contents.-- The regulations shall include:
(1) [Income eligibility] ELIGIBILITY criteria and other
standards and procedures for individuals participating in the
program, determined by the Department of [Public Welfare]
Human Services in conjunction with the board.
(2) Eligibility criteria and other standards and
procedures for entities participating in the program that
restock and distribute or dispense donated [cancer]
prescription drugs.
(3) Necessary forms for administration of the program,
including forms for use by entities permitted to accept,
distribute or dispense [cancer] PRESCRIPTION drugs under the
program.
(4) The maximum handling fee that may be charged by
entities permitted to restock and distribute or dispense
donated [cancer] prescription drugs.
(5) Categories of [cancer] prescription drugs that the
program will accept for dispensing and categories of [cancer]
prescription drugs that the program will not accept for
dispensing and the reason that the [cancer] prescription
drugs will not be accepted.
(6) Informed consent provision for patients
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participating in the program indicating that the [cancer]
prescription drug has been restocked and redistributed.
(7) Provisions for recalls of the drug if necessary.
(8) Procedures for entities participating in the program
to minimize theft and diversion.
Section 4 6. 49 Pa. Code §§ 27.501-27.506 shall remain in
full force and effect until the publication of the temporary
regulations under section 7(a) of this THE act.
Section 5 7. This act shall take effect in 60 days.
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