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                                 HOUSE AMENDED
        PRIOR PRINTER'S NOS. 690, 1218, 1411          PRINTER'S NO. 1615

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, WAUGH, C. WILLIAMS AND WASHINGTON, MARCH 21, 2007

        AS AMENDED ON SECOND CONSIDERATION, HOUSE OF REPRESENTATIVES,
           DECEMBER 4, 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.

     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     "APPROVED PARTICIPATING PHARMACY."  A PHARMACY APPROVED BY     <--
    15  THE STATE BOARD OF PHARMACY FOR THE PURPOSE OF DISPENSING UNUSED
    16  CANCER DRUGS TO PARTICIPATING ENTITIES AND TO PATIENTS WHO ARE


     1  INDIGENT.
     2     "Board."  The State Board of Pharmacy.
     3     "Cancer drug."  A prescription drug used to treat any of the
     4  following:
     5         (1)  Cancer or its side effects.
     6         (2)  The side effects of a prescription drug used to
     7     treat cancer or its side effects.
     8     "Closed drug delivery system."  A system in which the actual
     9  control of a unit dose medication is maintained by a health care
    10  facility, health clinic, hospital, pharmacy or physician's
    11  office rather than an individual patient.
    12     "Health care facility."  A for-profit or nonprofit entity
    13  providing clinically related health services, including those
    14  operated by the Commonwealth or its political subdivisions and
    15  including a general or special hospital, including psychiatric
    16  hospitals, rehabilitation hospitals, ambulatory surgical
    17  facilities, long-term care nursing facilities, a hospice, cancer
    18  treatment center using radiation therapy on an ambulatory basis
    19  and inpatient drug and alcohol treatment facility.
    20     "Health clinic."  A for-profit or nonprofit clinic providing
    21  health services.
    22     "Hospital."  An entity licensed as a hospital under:           <--
    23         (1)  the act of June 13, 1967 (P.L.31, No.21), known as
    24     the Public Welfare Code; or
    25         (2)  the act of July 19, 1979 (P.L.130, No.48), known as
    26     the Health Care Facilities Act.
    27     "HOSPITAL."  AN ENTITY LICENSED AS A HOSPITAL UNDER THE ACT    <--
    28  OF JULY 19, 1979 (P.L.130, NO.48), KNOWN AS THE HEALTH CARE
    29  FACILITIES ACT.
    30     "Pharmacist."  A pharmacist licensed by the Commonwealth.
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     1     "Pharmacy."  A pharmacy licensed by the Commonwealth.
     2     "Physician's office."  The office of a person licensed to
     3  practice medicine and surgery or osteopathic medicine and
     4  surgery.
     5     "Prescribing practitioner."  A health care practitioner
     6  licensed under the laws of this Commonwealth who is authorized
     7  to prescribe cancer drugs.
     8     "Prescription drug."  A drug requiring a prescription in this
     9  Commonwealth.
    10     "Program."  The Cancer Drug Repository Program established in
    11  section 3.
    12     "Unit dose system."  A system wherein all individually sealed
    13  unit doses are physically connected as a unit.
    14  Section 3.  Establishment.
    15     The board shall establish a Cancer Drug Repository Program
    16  consistent with public health and safety standards through which
    17  unused cancer drugs may be redispensed to cancer patients by
    18  pharmacies approved by the board for the purpose of dispensing
    19  unused cancer drugs to residents who are indigent. The board
    20  shall develop and promulgate rules and regulations to establish
    21  procedures necessary to implement the program. Participation in
    22  the program shall be voluntary.
    23  Section 4.  Restocking and dispensing of cancer drugs.
    24     An entity that is part of a closed drug delivery system may
    25  return to an approved participating pharmacy an unused cancer
    26  drug under the following conditions:
    27         (1)  If the cancer drug is in its original unopened,
    28     sealed and tamper-evident unit dose packaging. A cancer drug
    29     packaged in single-unit doses may be accepted and dispensed
    30     if the outside packaging is opened but the single-unit-dose
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     1     packaging is unopened.
     2         (2)  The cancer drug may not be accepted or dispensed by
     3     the approved participating pharmacy if the cancer drug bears
     4     an expiration date that is earlier than six months after the
     5     date the cancer drug was restocked or the cancer drug is
     6     adulterated or misbranded.
     7         (3)  Except as provided in this subsection, an unused
     8     cancer drug dispensed under a State medical assistance
     9     program may be accepted and dispensed by the approved
    10     participating pharmacy.
    11         (4)  In the case of controlled substances, as it is
    12     allowed by Federal law.
    13  Section 5.  Storage, distribution and fees.
    14     (a)  General rule.--An entity APPROVED PARTICIPATING PHARMACY  <--
    15  that accepts donated cancer drugs under the Cancer Drug
    16  Repository Program shall comply with all applicable provisions
    17  of Federal and State law relating to the storage, distribution
    18  and dispensing of cancer drugs and shall inspect all cancer
    19  drugs prior to dispensing to determine if they are adulterated
    20  or misbranded. The cancer drugs shall only be dispensed by a
    21  pharmacist according to State law pursuant to a prescription
    22  issued by a prescribing practitioner. The cancer drugs may be
    23  distributed to another participating physician's office,
    24  pharmacy, hospital or health clinic for dispensing by a
    25  pharmacist as allowed by Federal or State law.
    26     (b)  Handling fee.--A participating entity AN APPROVED         <--
    27  PARTICIPATING PHARMACY may charge a handling fee for
    28  distributing or dispensing cancer drugs under the program. The
    29  fee shall be established in regulations promulgated by the
    30  board. Cancer drugs donated under the program shall not be
    20070S0638B1615                  - 4 -     

     1  resold.
     2     (c)  No compensation for returned or redispensed drugs.--
     3         (1)  No participating health care facility, health
     4     clinic, hospital, pharmacist, pharmacy or physician's office
     5     that provides unused prescription drugs to the program in
     6     accordance with this act shall be required to compensate
     7     another entity for the cost of any drug returned and
     8     redispensed under this act.
     9         (2)  This subsection shall not apply to drugs dispensed
    10     under any Federal prescription drug program.
    11     (D)  RECORDKEEPING.--A PARTICIPATING ENTITY SHALL RECORD AND   <--
    12  LOG THE EXACT QUANTITY, NAME AND STRENGTH OF DRUG PRIOR TO
    13  RETURNING THE DRUGS TO AN APPROVED PARTICIPATING PHARMACY. THE
    14  APPROVED PARTICIPATING PHARMACY THAT RECEIVES THE DRUG SHALL
    15  RECORD RECEIPT AND VERIFY THE QUANTITY OF DRUGS.
    16  Section 6.  Immunity.
    17     Any person or entity, acting in good faith, who exercises
    18  reasonable care in donating, accepting, distributing, dispensing
    19  or manufacturing cancer drugs donated and utilized under the
    20  program shall be immune from civil or criminal liability or
    21  professional disciplinary action for any injury, death or loss
    22  to a person or property relating to activities under the
    23  program. Immunity granted under this paragraph is solely
    24  applicable to the donation, acceptance, distribution, dispensing
    25  or manufacture of the actual medications donated to the program
    26  and is explicitly not a general waiver of liability.
    27  Section 7.  Regulations.
    28     The board shall promulgate regulations to carry out the
    29  purposes of this act within 90 days of the effective date of
    30  this section. The regulations shall include:
    20070S0638B1615                  - 5 -     

     1         (1)  INCOME ELIGIBILITY CRITERIA AND OTHER STANDARDS AND   <--
     2     PROCEDURES FOR INDIVIDUALS PARTICIPATING IN THE PROGRAM,
     3     DETERMINED BY THE DEPARTMENT OF PUBLIC WELFARE IN CONJUNCTION
     4     WITH THE BOARD.
     5         (1) (2)  Eligibility criteria and other standards and      <--
     6     procedures for entities participating in the program that
     7     restock and distribute or dispense donated cancer drugs.
     8         (2) (3)  Necessary forms for administration of the         <--
     9     program, including forms for use by entities permitted to
    10     accept, distribute or dispense cancer drugs under the
    11     program.
    12         (3) (4)  The maximum handling fee that may be charged by   <--
    13     entities permitted to restock and distribute or dispense
    14     donated cancer drugs.
    15         (4) (5)  Categories of cancer drugs that the program will  <--
    16     accept for dispensing and categories of cancer drugs that the
    17     program will not accept for dispensing and the reason that
    18     the cancer drugs will not be accepted.
    19         (5) (6)  Informed consent provision for patients           <--
    20     participating in the program indicating that the cancer drug
    21     has been restocked and redistributed.
    22         (6) (7)  Provisions for recalls of the drug if necessary.  <--
    23         (7) (8)  PROCEDURES FOR ENTITIES PARTICIPATING IN THE      <--
    24     PROGRAM TO MINIMIZE THEFT AND DIVERSION.
    25  Section 25.  Effective date.
    26     This act shall take effect in 60 days.



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