PRINTER'S NO. 4226
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
2709
Session of
2018
INTRODUCED BY CUTLER, SOLOMON, J. McNEILL, TOEPEL, MILLARD,
R. BROWN, MENTZER, SCHLEGEL CULVER, WARD, DRISCOLL, KAUFER,
HILL-EVANS, COX, GROVE AND B. MILLER, OCTOBER 12, 2018
REFERRED TO COMMITTEE ON HEALTH, OCTOBER 12, 2018
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 of program, for
restocking and dispensing of cancer drugs, for storage,
distribution and fees, for immunity and for regulations.
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),
6 and 7 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 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]
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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:
"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 act
of April 14, 1972 (P.L.233, No.64), known as The Controlled
Substance, Drug, Device and Cosmetic Act.
"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
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
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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.
"Pharmacist." A pharmacist licensed by the Commonwealth.
"Pharmacy." A pharmacy licensed by the Commonwealth.
"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.]
Section 3. Establishment.
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
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procedures necessary to implement the program. 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 or health clinic may
return to an approved participating pharmacy an unused [cancer]
prescription drug under the following conditions:
(1) If the [cancer] 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 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.]
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 the
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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 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.
* * *
Section 6. Immunity.
Any person or entity, acting in good faith, who exercises
reasonable care in donating, accepting, distributing, dispensing
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.
Section 7. Regulations.
The board shall promulgate regulations to carry out the
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purposes of this act [within 90 days of the effective date of
this section]. The regulations shall include:
(1) Income 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
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 2. This act shall take effect in 60 days.
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