PRIOR PRINTER'S NO. 3631 PRINTER'S NO. 4734
No. 2482 Session of 2006
INTRODUCED BY SOLOBAY, DeWEESE, COHEN, BEBKO-JONES, BEYER, BUNT,
CALTAGIRONE, CAPPELLI, CORNELL, CRAHALLA, DENLINGER,
DONATUCCI, J. EVANS, FABRIZIO, FRANKEL, FREEMAN, GEORGE,
GINGRICH, GODSHALL, GOODMAN, GRUCELA, HENNESSEY, HERSHEY,
HESS, JAMES, LaGROTTA, LEACH, LEDERER, MANN, MILLARD, MUNDY,
MYERS, PALLONE, PHILLIPS, PISTELLA, READSHAW, REICHLEY,
SCHRODER, SIPTROTH, STABACK, THOMAS, TIGUE, WALKO, WANSACZ,
WOJNAROSKI, YOUNGBLOOD AND GEIST, MARCH 6, 2006
AS REPORTED FROM COMMITTEE ON HEALTH AND HUMAN SERVICES, HOUSE
OF REPRESENTATIVES, AS AMENDED, OCTOBER 3, 2006
AN ACT
1 Establishing the Cancer Drug Repository Program for accepting
2 donated cancer drugs and dispensing cancer drugs.
3 The General Assembly of the Commonwealth of Pennsylvania
4 hereby enacts as follows:
5 Section 1. Short title.
6 This act shall be known and may be cited as the Cancer Drug
7 Repository Program Act.
8 Section 2. Definitions.
9 The following words and phrases when used in this act shall
10 have the meanings given to them in this section unless the
11 context clearly indicates otherwise:
12 "BOARD." THE STATE BOARD OF PHARMACY. <--
13 "Cancer drug." A prescription drug used to treat any of the
14 following:
1 (1) Cancer or its side effects.
2 (2) The side effects of a prescription drug used to
3 treat cancer or its side effects.
4 "Department." The Department of Health of the Commonwealth. <--
5 "Health care facility." A for-profit or nonprofit entity
6 providing clinically related health services, including those
7 operated by the Commonwealth or its political subdivisions and
8 including a general or special hospital, including psychiatric
9 hospitals, rehabilitation hospitals, ambulatory surgical
10 facilities, long-term care nursing facilities, a hospice, cancer
11 treatment center using radiation therapy on an ambulatory basis
12 and inpatient drug and alcohol treatment facility.
13 "Health clinic." A for-profit or nonprofit clinic providing
14 health services.
15 "Hospital." An entity licensed as a hospital under:
16 (1) the act of June 13, 1967 (P.L.31, No.21), known as
17 the Public Welfare Code; or
18 (2) the act of July 19, 1979 (P.L.130, No.48), known as
19 the Health Care Facilities Act.
20 "Pharmacy." A pharmacy licensed by the Commonwealth.
21 "Physician's office." The office of a person licensed to
22 practice medicine and surgery or osteopathic medicine and
23 surgery.
24 "Prescribing practitioner." A health care practitioner
25 licensed under the laws of this Commonwealth who is authorized
26 to prescribe cancer drugs.
27 "Prescription drug." All drugs requiring a prescription in
28 this Commonwealth.
29 "Program." The Cancer Drug Repository Program established in
30 section 3.
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1 Section 3. Establishment.
2 The department BOARD shall establish a Cancer Drug Repository <--
3 Program for accepting donated cancer drugs and dispensing cancer
4 drugs to residents of this Commonwealth. Participation in the
5 program shall be voluntary.
6 Section 4. Donation of cancer drugs.
7 Any person or entity, including, but not limited to, a cancer
8 drug manufacturer or health care facility, may donate cancer
9 drugs to the program. Cancer drugs may be donated at a
10 physician's office, pharmacy, hospital or health clinic that
11 elects to participate in the program and meets the criteria
12 established by the department BOARD for participation. <--
13 Section 5. Acceptance and dispensation of cancer drugs.
14 (1) A cancer drug shall only be accepted or dispensed
15 under the program if the drug is in its original unopened,
16 sealed and tamper-evident unit dose packaging. A cancer drug
17 packaged in single-unit doses may be accepted and dispensed
18 if the outside packaging is opened but the single-unit-dose
19 packaging is unopened.
20 (2) A cancer drug shall not be accepted or dispensed
21 under the program if the drug bears an expiration date that
22 is earlier than six months after the date the drug was
23 donated or the drug is adulterated or misbranded.
24 (3) Except as provided in this subsection, unused cancer
25 drugs dispensed under a State medical assistance program may
26 be accepted and dispensed under the program.
27 Section 6. Storage, distribution and fees.
28 (1) A physician's office, pharmacy, hospital or health
29 clinic that accepts donated cancer drugs under the program
30 shall comply with all applicable provisions of Federal and
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1 State law relating to the storage, distribution and
2 dispensing of cancer drugs and shall inspect all cancer drugs
3 prior to dispensing to determine if they are adulterated or
4 misbranded. The drugs shall only be dispensed pursuant to a
5 prescription issued by a prescribing practitioner. The drugs
6 may be distributed to another participating physician's
7 office, pharmacy, hospital or health clinic for dispensing.
8 (2) A physician's office, pharmacy, hospital or health
9 clinic may charge a handling fee for distributing or
10 dispensing cancer drugs under the program. The fee shall be
11 established in regulations promulgated by the department <--
12 BOARD. Cancer drugs donated under the program shall not be <--
13 resold.
14 Section 7. Immunity.
15 (1) Any person or entity, including a cancer drug
16 manufacturer, which exercises reasonable care in donating,
17 accepting, distributing or dispensing cancer drugs under the
18 program shall be immune from civil or criminal liability or
19 professional disciplinary action for any injury, death or
20 loss to a person or property relating to such activities.
21 (2) Notwithstanding paragraph (1), the donation of a
22 cancer drug by a cancer drug manufacturer shall not:
23 (i) Absolve the manufacturer of any criminal or
24 civil liability that would have existed except for the
25 donation.
26 (ii) Increase the liability of the cancer drug
27 manufacturer that would have existed except for the
28 donation.
29 Section 8. Regulations.
30 The department BOARD shall promulgate regulations to carry <--
20060H2482B4734 - 4 -
1 out the purposes of this act within 90 days of the effective
2 date of this act. The regulations shall include:
3 (1) Eligibility criteria and other standards and
4 procedures for physician's offices, pharmacies, PHARMACISTS, <--
5 hospitals and health clinics that accept and distribute or
6 dispense donated cancer drugs.
7 (2) Necessary forms for administration of the program,
8 including forms for use by persons or entities that donate, <--
9 accept, distribute or dispense cancer drugs under the
10 program.
11 (3) The maximum handling fee that may be charged by
12 physician's offices, pharmacies, hospitals or health clinics
13 that accept and distribute or dispense donated cancer drugs.
14 (4) Categories of cancer drugs that the program will
15 accept for dispensing and categories of cancer drugs that the
16 program will not accept for dispensing and the reason that
17 the drugs will not be accepted.
18 Section 25. Effective date.
19 This act shall take effect in 60 days.
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