HOUSE AMENDED PRIOR PRINTER'S NOS. 690, 1218, 1411 PRINTER'S NO. 1615
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. 20070S0638B1615 - 2 -
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 20070S0638B1615 - 3 -
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. C6L35DMS/20070S0638B1615 - 6 -