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 and for list of approved participating pharmacies; further providing for regulations; and imposing duties on the State Board of Pharmacy.

PRINTER'S NO.   57

                     THE GENERAL ASSEMBLY OF PENNSYLVANIA



                         HOUSE BILL
                         No. 69
                                               Session of
                                                 2025

     INTRODUCED BY CUTLER, VENKAT, JAMES, NEILSON, RAPP, KAUFFMAN,
        CIRESI, MENTZER, GUENST, KUZMA AND PICKETT, JANUARY 14, 2025

     REFERRED TO COMMITTEE ON HEALTH, JANUARY 14, 2025


                                    AN ACT
 1   Amending the act of May 13, 2008 (P.L.139, No.14), entitled "An
 2      act establishing the Cancer Drug Repository Program for
 3      accepting donated cancer drugs and dispensing cancer drugs;
 4      and providing for the powers and duties of the State Board of
 5      Pharmacy," further providing for title and short title of
 6      act, for definitions, for establishment, for restocking and
 7      dispensing of cancer drugs, for storage, distribution and
 8      fees and for immunity; providing for annual report and for
 9      list of approved participating pharmacies; further providing
10      for regulations; and imposing duties on the State Board of
11      Pharmacy.
12      The General Assembly of the Commonwealth of Pennsylvania
13   hereby enacts as follows:
14      Section 1.    The title and sections 1, 2, 3, 4, 5(a) and (b)
15   and 6 of the act of May 14, 2008 (P.L.139, No.14), known as the
16   Cancer Drug Repository Program Act, are amended to read:
17                                  AN ACT
18   Establishing the [Cancer] Prescription Drug Repository Program
19      for accepting donated [cancer] prescription drugs and
20      dispensing [cancer] prescription drugs; and providing for the
21      powers and duties of the State Board of Pharmacy.
22   Section 1.   Short title.
 1      This act shall be known and may be cited as the [Cancer]
 2   Prescription Drug Repository Program Act.
 3   Section 2.    Definitions.
 4      The following words and phrases when used in this act shall
 5   have the meanings given to them in this section unless the
 6   context clearly indicates otherwise:
 7      "Adulterated."    As specified under section 7 of the act of
 8   April 14, 1972 (P.L.233, No.64), known as The Controlled
 9   Substance, Drug, Device and Cosmetic Act.
10      "Approved participating pharmacy."    A pharmacy approved by
11   the State Board of Pharmacy for the purpose of dispensing unused
12   [cancer] prescription drugs to participating entities and to
13   patients who are indigent.
14      "Board."    The State Board of Pharmacy of the Commonwealth.
15      "Cancer drug."    A prescription drug used to treat any of the
16   following:
17          (1)    Cancer or its side effects.
18          (2)    The side effects of a prescription drug used to
19      treat cancer or its side effects.
20      ["Closed drug delivery system."     A system in which the actual
21   control of a unit dose medication is maintained by a health care
22   facility, health clinic, hospital, pharmacy or physician's
23   office rather than an individual patient.]
24      "Controlled substance."    As defined in section 2 of The
25   Controlled Substance, Drug, Device and Cosmetic Act.
26      "Health care facility."    [A for-profit or nonprofit entity
27   providing clinically related health services, including those
28   operated by the Commonwealth or its political subdivisions and
29   including a general or special hospital, including psychiatric
30   hospitals, rehabilitation hospitals, ambulatory surgical

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 1   facilities, long-term care nursing facilities, a hospice, a
 2   cancer treatment center using radiation therapy on an ambulatory
 3   basis and an inpatient drug and alcohol treatment facility.] As
 4   defined in section 802.1 of the act of July 19, 1979 (P.L.130,
 5   No.48), known as the Health Care Facilities Act.
 6      "Health clinic."     A for-profit or nonprofit clinic providing
 7   health services.
 8      "Hospital."     An entity licensed as a hospital under the [act
 9   of July 19, 1979 (P.L.130, No.48), known as the] Health Care
10   Facilities Act.
11      "Manufacturer."     As defined in section 2 of The Controlled
12   Substance, Drug, Device and Cosmetic Act.
13      "Misbranded."     As specified under section 8 of The Controlled
14   Substance, Drug, Device and Cosmetic Act.
15      "Pharmacist."     A pharmacist licensed by the Commonwealth.
16      "Pharmacy."     A pharmacy licensed by the Commonwealth.
17      "Physician's office."     The office of a person licensed to
18   practice medicine and surgery or osteopathic medicine and
19   surgery.
20      "Prescribing practitioner."     A health care practitioner
21   licensed under the laws of this Commonwealth who is authorized
22   to prescribe [cancer] prescription drugs.
23      "Prescription drug."     A drug requiring a prescription in this
24   Commonwealth. The term includes cancer drugs. The term does not
25   include a controlled substance.
26      "Program."     The [Cancer] Prescription Drug Repository Program
27   established in section 3.
28      ["Unit dose system."     A system wherein all individually
29   sealed unit doses are physically connected as a unit.]
30      "Wholesale distributor of prescription drugs."     As defined in

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 1   section 3 of the act of December 14, 1992 (P.L.1116, No.145),
 2   known as the Wholesale Prescription Drug Distributors License
 3   Act.
 4   Section 3.   Establishment.
 5      The board shall establish a [Cancer] Prescription Drug
 6   Repository Program consistent with public health and safety
 7   standards through which unused [cancer] prescription drugs may
 8   be redispensed to [cancer] patients by pharmacies approved by
 9   the board for the purpose of dispensing unused [cancer]
10   prescription drugs to residents who are indigent. The board
11   shall develop and promulgate rules and regulations to establish
12   procedures necessary to implement the program. Participation in
13   the program shall be voluntary.
14   Section 4.   Restocking and dispensing of [cancer] prescription
15                drugs.
16      An [entity that is part of a closed drug delivery system]
17   individual, health care facility, hospital, health clinic,
18   manufacturer or wholesale distributor of prescription drugs may
19   return or donate to an approved participating pharmacy an unused
20   [cancer] prescription drug under the following conditions:
21          (1)     [If the cancer] The prescription drug is in its
22      original unopened, sealed and tamper-evident [unit dose]
23      packaging. A [cancer] prescription drug packaged in single-
24      unit doses may be accepted and dispensed if the outside
25      packaging is opened but the single-unit-dose packaging is
26      unopened.
27          (2)     The [cancer] prescription drug may not be accepted
28      or dispensed by the approved participating pharmacy if the
29      [cancer] prescription drug bears an expiration date that is
30      earlier than six months after the date the [cancer]

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 1      prescription drug was restocked or the [cancer] prescription
 2      drug is adulterated or misbranded.
 3            [(3)    Except as provided in this subsection, an unused
 4      cancer drug dispensed under a State medical assistance
 5      program may be accepted and dispensed by the approved
 6      participating pharmacy.
 7            (4)    In the case of controlled substances, as it is
 8      allowed by Federal law.]
 9            (5)    Subject to this act and except as otherwise
10      prohibited by Federal or State law, an unused prescription
11      drug dispensed under a State medical assistance program may
12      be accepted and dispensed by an approved participating
13      pharmacy.
14   Section 5.      Storage, distribution and fees.
15      (a)   General rule.--An approved participating pharmacy that
16   accepts donated [cancer] prescription drugs under the [Cancer]
17   Prescription Drug Repository Program shall comply with all
18   applicable provisions of Federal and State law [relating to],
19   including the storage, distribution and dispensing of [cancer]
20   prescription drugs and shall inspect all [cancer] prescription
21   drugs prior to dispensing to determine if they are adulterated
22   or misbranded. The [cancer] prescription drugs shall only be
23   dispensed by a pharmacist according to State law pursuant to a
24   prescription issued by a prescribing practitioner. The [cancer]
25   prescription drugs may be distributed to another participating
26   physician's office, pharmacy, hospital or health clinic for
27   dispensing by a pharmacist as allowed by Federal or State law.
28      (b)   Handling fee.--An approved participating pharmacy may
29   charge a handling fee for distributing or dispensing [cancer]
30   prescription drugs under the program. The fee shall be

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 1   established in regulations promulgated by the board. [Cancer]
 2   Prescription drugs donated under the program shall not be
 3   resold.
 4      * * *
 5   Section 6.      Immunity.
 6      Any person or entity, acting in good faith, who exercises
 7   reasonable care in donating, accepting, distributing, dispensing
 8   or manufacturing [cancer] prescription drugs donated and
 9   utilized under the program shall be immune from civil or
10   criminal liability or professional disciplinary action for any
11   injury, death or loss to a person or property relating to
12   activities under the program. Immunity granted under this
13   section is solely applicable to the donation, acceptance,
14   distribution, dispensing or manufacture of the actual
15   medications donated to the program and is explicitly not a
16   general waiver of liability.
17      Section 2.      The act is amended by adding sections to read:
18   Section 6.1.      Annual report.
19      (a)    Report.--The board shall report annually by December 31
20   of each year on the progress in implementing and administering
21   this act and submit the report to all of the following:
22             (1)   The chairperson and minority chairperson of the
23      Health and Human Services Committee of the Senate.
24             (2)   The chairperson and minority chairperson of the
25      Health Committee of the House of Representatives.
26             (3)   The chairperson and minority chairperson of the
27      Consumer Protection and Professional Licensure Committee of
28      the Senate.
29             (4)   The chairperson and minority chairperson of the
30      Professional Licensure Committee of the House of

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 1      Representatives.
 2      (b)   Contents.--A report under subsection (a) shall include
 3   all of the following information:
 4            (1)   The name and address of each approved participating
 5      pharmacy in the program.
 6            (2)   The number of approved participating pharmacies in
 7      the program by county.
 8            (3)   The number of approved participating pharmacies that
 9      have withdrawn from the program.
10            (4)   The number of pharmacies that the board has refused
11      to approve, has revoked or has suspended from participating
12      in the program.
13            (5)   Recommendations to the General Assembly for
14      improvements or changes to the program as the board deems
15      necessary.
16   Section 6.2.     List of approved participating pharmacies.
17      The board shall post on the board's publicly accessible
18   Internet website a list of each approved participating pharmacy,
19   including the address and telephone number of each approved
20   participating pharmacy. The board shall update the list under
21   this section within 30 days of a change in the list and note the
22   change from the previous list on the board's publicly accessible
23   Internet website.
24      Section 3.     Section 7 of the act is amended to read:
25   Section 7.     Regulations.
26      [The board shall promulgate regulations to carry out the
27   purposes of this act within 90 days of the effective date of
28   this section. The regulations shall include:]
29      (a)   Authority.--In order to facilitate the prompt
30   implementation of this act, the board shall promulgate temporary

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 1   regulations that shall expire no later than two years following
 2   the publication of the temporary regulations. The board may
 3   promulgate temporary regulations not subject to:
 4            (1)   Section 612 of the act of April 9, 1929 (P.L.177,
 5      No.175), known as The Administrative Code of 1929.
 6            (2)   Sections 201, 202, 203, 204 and 205 of the act of
 7      July 31, 1968 (P.L.769, No.240), referred to as the
 8      Commonwealth Documents Law.
 9            (3)   Sections 204(b) and 301(10) of the act of October
10      15, 1980 (P.L.950, No.164), known as the Commonwealth
11      Attorneys Act.
12            (4)   The act of June 25, 1982 (P.L.633, No.181), known as
13      the Regulatory Review Act.
14      (b)   Expiration.--The board's authority to adopt temporary
15   regulations under subsection (a) shall expire two years after
16   the effective date of this subsection. Regulations adopted after
17   this period shall be promulgated as provided by law before the
18   expiration of the temporary regulations under subsection (a).
19      (c)   Contents.--The regulations shall include:
20            (1)   Income eligibility criteria and other standards and
21      procedures for individuals participating in the program,
22      determined by the Department of [Public Welfare] Human
23      Services in conjunction with the board.
24            (2)   Eligibility criteria and other standards and
25      procedures for entities participating in the program that
26      restock and distribute or dispense donated [cancer]
27      prescription drugs.
28            (3)   Necessary forms for administration of the program,
29      including forms for use by entities permitted to accept,
30      distribute or dispense cancer drugs under the program.

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 1          (4)   The maximum handling fee that may be charged by
 2      entities permitted to restock and distribute or dispense
 3      donated [cancer] prescription drugs.
 4          (5)   Categories of [cancer] prescription drugs that the
 5      program will accept for dispensing and categories of [cancer]
 6      prescription drugs that the program will not accept for
 7      dispensing and the reason that the [cancer] prescription
 8      drugs will not be accepted.
 9          (6)   Informed consent provision for patients
10      participating in the program indicating that the [cancer]
11      prescription drug has been restocked and redistributed.
12          (7)   Provisions for recalls of the drug if necessary.
13          (8)   Procedures for entities participating in the program
14      to minimize theft and diversion.
15      Section 4.   49 Pa. Code §§ 27.501-27.506 shall remain in full
16   force and effect until the publication of the temporary
17   regulations under section 7(a) of this act.
18      Section 5.   This act shall take effect in 60 days.




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