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                                                       PRINTER'S NO. 690

THE GENERAL ASSEMBLY OF PENNSYLVANIA


SENATE BILL

No. 638 Session of 2007


        INTRODUCED BY WONDERLING, ERICKSON, KITCHEN, BOSCOLA,
           TARTAGLIONE, FONTANA, GORDNER, MUSTO, STOUT, PUNT, CORMAN,
           STACK, TOMLINSON, RAFFERTY, FERLO, ORIE, COSTA, O'PAKE,
           GREENLEAF, REGOLA, WOZNIAK, BROWNE, MELLOW, EARLL, RHOADES,
           M. WHITE AND WAUGH, MARCH 21, 2007

        REFERRED TO PUBLIC HEALTH AND WELFARE, MARCH 21, 2007

                                     AN ACT

     1  Establishing the Cancer Drug Repository Program for accepting
     2     donated cancer drugs and dispensing cancer drugs; and
     3     providing for the powers and duties of the State Board of
     4     Pharmacy and the Department of Health.

     5     The General Assembly of the Commonwealth of Pennsylvania
     6  hereby enacts as follows:
     7  Section 1.  Short title.
     8     This act shall be known and may be cited as the Cancer Drug
     9  Repository Program Act.
    10  Section 2.  Definitions.
    11     The following words and phrases when used in this act shall
    12  have the meanings given to them in this section unless the
    13  context clearly indicates otherwise:
    14     "Board."  The State Board of Pharmacy.
    15     "Cancer drug."  A prescription drug used to treat any of the
    16  following:
    17         (1)  Cancer or its side effects.


     1         (2)  The side effects of a prescription drug used to
     2     treat cancer or its side effects.
     3     "Closed drug delivery system."  A system in which the actual
     4  control of a unit dose medication is maintained by a health care
     5  facility, health clinic, hospital, pharmacy or physician's
     6  office rather than an individual patient.
     7     "Department."  The Department of Health of the Commonwealth.
     8     "Health care facility."  A for-profit or nonprofit entity
     9  providing clinically related health services, including those
    10  operated by the Commonwealth or its political subdivisions and
    11  including a general or special hospital, including psychiatric
    12  hospitals, rehabilitation hospitals, ambulatory surgical
    13  facilities, long-term care nursing facilities, a hospice, cancer
    14  treatment center using radiation therapy on an ambulatory basis
    15  and inpatient drug and alcohol treatment facility.
    16     "Health clinic."  A for-profit or nonprofit clinic providing
    17  health services.
    18     "Hospital."  An entity licensed as a hospital under:
    19         (1)  the act of June 13, 1967 (P.L.31, No.21), known as
    20     the Public Welfare Code; or
    21         (2)  the act of July 19, 1979 (P.L.130, No.48), known as
    22     the Health Care Facilities Act.
    23     "Pharmacist."  A pharmacist licensed by the Commonwealth.
    24     "Pharmacy."  A pharmacy licensed by the Commonwealth.
    25     "Physician's office."  The office of a person licensed to
    26  practice medicine and surgery or osteopathic medicine and
    27  surgery.
    28     "Prescribing practitioner."  A health care practitioner
    29  licensed under the laws of this Commonwealth who is authorized
    30  to prescribe cancer drugs.
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     1     "Prescription drug."  A drug requiring a prescription in this
     2  Commonwealth.
     3     "Program."  The Cancer Drug Repository Program established in
     4  section 3.
     5     "Unit dose system."  A system wherein all individually sealed
     6  unit doses are physically connected as a unit.
     7  Section 3.  Establishment.
     8     The board shall establish a Cancer Drug Repository Program
     9  consistent with public health and safety standards through which
    10  unused cancer drugs may be redispensed to cancer patients by
    11  pharmacies approved by the board for the purpose of dispensing
    12  unused cancer drugs to residents who are indigent. The board
    13  shall develop and promulgate rules and regulations to establish
    14  procedures necessary to implement the program. Participation in
    15  the program shall be voluntary.
    16  Section 4.  Restocking and dispensing of cancer drugs.
    17     An entity that is part of a closed drug delivery system may
    18  return to an approved participating pharmacy an unused cancer
    19  drug under the following conditions:
    20         (1)  If the cancer drug is in its original unopened,
    21     sealed and tamper-evident unit dose packaging. A cancer drug
    22     packaged in single-unit doses may be accepted and dispensed
    23     if the outside packaging is opened but the single-unit-dose
    24     packaging is unopened.
    25         (2)  The cancer drug may not be accepted or dispensed by
    26     the approved participating pharmacy if the cancer drug bears
    27     an expiration date that is earlier than six months after the
    28     date the cancer drug was restocked or the cancer drug is
    29     adulterated or misbranded.
    30         (3)  Except as provided in this subsection, an unused
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     1     cancer drug dispensed under a State medical assistance
     2     program may be accepted and dispensed by the approved
     3     participating pharmacy.
     4         (4)  In the case of controlled substances, as it is
     5     allowed by Federal law.
     6  Section 5.  Storage, distribution and fees.
     7     (a)  General rule.--An entity that accepts donated cancer
     8  drugs under the Cancer Drug Repository Program shall comply with
     9  all applicable provisions of Federal and State law relating to
    10  the storage, distribution and dispensing of cancer drugs and
    11  shall inspect all cancer drugs prior to dispensing to determine
    12  if they are adulterated or misbranded. The cancer drugs shall
    13  only be dispensed by a pharmacist according to State law
    14  pursuant to a prescription issued by a prescribing practitioner.
    15  The cancer drugs may be distributed to another participating
    16  physician's office, pharmacy, hospital or health clinic for
    17  dispensing by a pharmacist as allowed by Federal or State law.
    18     (b)  Handling fee.--A participating entity may charge a
    19  handling fee for distributing or dispensing cancer drugs under
    20  the program. The fee shall be established in regulations
    21  promulgated by the board. Cancer drugs donated under the program
    22  shall not be resold.
    23     (c)  No compensation for returned or redispensed drugs.--
    24         (1)  No participating health care facility, health
    25     clinic, hospital, pharmacist, pharmacy or physician's office
    26     that provides unused prescription drugs to the program in
    27     accordance with this act shall be required to compensate
    28     another entity for the cost of any drug returned and
    29     redispensed under this act.
    30         (2)  This subsection shall not apply to drugs dispensed
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     1     under any Federal prescription drug program.
     2  Section 7.  Immunity.
     3     Any person or entity, acting in good faith, who exercises
     4  reasonable care in donating, accepting, distributing, dispensing
     5  or manufacturing cancer drugs donated and utilized under the
     6  program shall be immune from civil or criminal liability or
     7  professional disciplinary action for any injury, death or loss
     8  to a person or property relating to activities under the
     9  program. Immunity granted under this paragraph is solely
    10  applicable to the donation, acceptance, distribution, dispensing
    11  or manufacture of the actual medications donated to the program
    12  and is explicitly not a general waiver of liability.
    13  Section 8.  Regulations.
    14     The board shall promulgate regulations to carry out the
    15  purposes of this act within 90 days of the effective date of
    16  this section. The regulations shall include:
    17         (1)  Eligibility criteria and other standards and
    18     procedures for entities participating in the program that
    19     restock and distribute or dispense donated cancer drugs.
    20         (2)  Necessary forms for administration of the program,
    21     including forms for use by entities permitted to accept,
    22     distribute or dispense cancer drugs under the program.
    23         (3)  The maximum handling fee that may be charged by
    24     entities permitted to restock and distribute or dispense
    25     donated cancer drugs.
    26         (4)  Categories of cancer drugs that the program will
    27     accept for dispensing and categories of cancer drugs that the
    28     program will not accept for dispensing and the reason that
    29     the cancer drugs will not be accepted.
    30         (5)  Informed consent provision for patients
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     1     participating in the program indicating that the cancer drug
     2     has been restocked and redistributed.
     3         (6)  Provisions for recalls of the drug if necessary.
     4  Section 25.  Effective date.
     5     This act shall take effect in 60 days.

















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