PRIOR PRINTER'S NO. 690 PRINTER'S NO. 1218
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
SENATOR ARMSTRONG, APPROPRIATIONS, RE-REPORTED AS AMENDED, JUNE 25, 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 20070S0638B1218 - 3 -
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 20070S0638B1218 - 4 -
1 under any Federal prescription drug program. 2 Section 7 6. 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 7. 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 20070S0638B1218 - 5 -
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. C6L35DMS/20070S0638B1218 - 6 -