A04851
THE GENERAL ASSEMBLY OF PENNSYLVANIA
HOUSE BILL
No.
2363
Session of
2024
INTRODUCED BY CUTLER, GREINER, PICKETT, KINSEY, MOUL, STAATS,
ROWE, STENDER, SCHEUREN, GILLEN, HADDOCK, E. NELSON AND
MENTZER, JUNE 3, 2024
REFERRED TO COMMITTEE ON HEALTH, JUNE 3, 2024
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 and for immunity, providing for annual
report and for list of approved participating pharmacies and
further providing 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)
and 6 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.
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
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
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
A04851 - 2 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
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.
"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.
"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.]
"Wholesale distributor of prescription drugs." As defined in
A04851 - 3 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
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.
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 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 ,
manufacturer or wholesale distributor of prescription drugs 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
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]
A04851 - 4 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
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 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
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
A04851 - 5 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
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 2. 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.
(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
A04851 - 6 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
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) 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.
Section 3. 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.]
(a) Authority.--In order to facilitate the prompt
implementation of this act, the board may promulgate temporary
A04851 - 7 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
regulations that shall expire no later than two years following
the publication of the temporary regulations. The board must
promulgate the temporary regulations within 180 days of the
effective date of this subsection. 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.
(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. 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 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,
A04851 - 8 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23
24
25
26
27
28
29
30
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.
(d) Applicability.--The regulations promulgated by the board
as published in the Pennsylvania Bulletin at 43 Pa.B. 7011
(November 27, 2013) and effective November 30, 2013, shall
remain in full force and effect until the promulgation of the
temporary regulations under subsection (a).
Section 4. This act shall take effect in 60 days.
A04851 - 9 -
1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
16
17
18
19
20
21
22
23