HB69: Further providing for title and short title of act, for definitions, for establishment, for…

THE TITLE AND SECTIONS 1, 2, 3 AND 4 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 <-- <-- <-- <-- 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 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] 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 20250HB0069PN3487 - 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 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 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. "INDIGENT." AN INDIVIDUAL WHO LACKS SUFFICIENT FINANCIAL RESOURCES TO OBTAIN PRESCRIPTION MEDICATIONS, INCLUDING AN INDIVIDUAL WHO IS UNINSURED, UNDERINSURED, ENROLLED IN A PUBLIC ASSISTANCE HEALTH BENEFITS PROGRAM OR WHOSE HOUSEHOLD INCOME DOES NOT EXCEED A THRESHOLD ESTABLISHED BY THE BOARD THROUGH REGULATION. "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. "PHARMACY BENEFITS MANAGER." AN ENTITY THAT PERFORMS PHARMACY BENEFITS MANAGEMENT AS DEFINED IN SECTION 103 OF THE ACT OF NOVEMBER 21, 2016 (P.L.1318, NO.169), KNOWN AS THE PHARMACY AUDIT INTEGRITY AND TRANSPARENCY ACT. 20250HB0069PN3487 - 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 "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.] "REVERSE DISTRIBUTOR." A PERSON LICENSED OR REGISTERED TO RECEIVE PRESCRIPTION DRUGS FOR THE PURPOSE OF RETURNING, PROCESSING OR DESTROYING THE PRESCRIPTION DRUGS IN ACCORDANCE WITH FEDERAL AND STATE LAW. "THIRD-PARTY LOGISTICS PROVIDER." AN ENTITY THAT PROVIDES OR COORDINATES WAREHOUSING OR OTHER LOGISTICS SERVICES FOR A PRODUCT ON BEHALF OF A MANUFACTURER, WHOLESALE DISTRIBUTOR OR DISPENSER BUT DOES NOT TAKE OWNERSHIP OF THE PRODUCT OR HAVE RESPONSIBILITY TO DIRECT THE SALE OR DISPOSITION OF THE PRODUCT. "UNDERINSURED." AN INDIVIDUAL WHO HAS HEALTH INSURANCE COVERAGE BUT WHOSE INSURANCE DOES NOT ADEQUATELY COVER THE COST OF A PRESCRIPTION DRUG, INCLUDING DUE TO COPAYMENTS, COINSURANCE, DEDUCTIBLES, FORMULARY RESTRICTIONS OR COVERAGE LIMITATIONS, RESULTING IN FINANCIAL DIFFICULTY OBTAINING THE PRESCRIPTION DRUG. "UNINSURED." AN INDIVIDUAL WHO DOES NOT HAVE HEALTH INSURANCE COVERAGE THAT PROVIDES PRESCRIPTION DRUG BENEFITS. 20250HB0069PN3487 - 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 "Wholesale distributor of prescription drugs." As defined in 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. (A) DUTY OF BOARD.--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 PROGRAM. (B) PARTICIPATION.--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 , health clinic , manufacturer or , wholesale distributor of prescription drugs , REVERSE DISTRIBUTOR, THIRD-PARTY LOGISTICS PROVIDER, PHARMACY BENEFITS MANAGER OR OTHER ENTITY APPROVED BY THE BOARD BY REGULATION 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 20250HB0069PN3487 - 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 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.] (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(A) AND (B) OF THE ACT ARE AMENDED AND THE SECTION IS AMENDED BY ADDING SUBSECTIONS TO READ: 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 20250HB0069PN3487 - 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 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.] NOTHING IN THIS SECTION SHALL BE CONSTRUED TO AUTHORIZE A PARTICIPATING PHARMACY OR OTHER ENTITY TO RESELL A DONATED PRESCRIPTION DRUG. * * * (E) DRUG SUPPLY CHAIN SECURITY.--A DONATED PRESCRIPTION DRUG SHALL COMPLY WITH APPLICABLE FEDERAL AND STATE DRUG SUPPLY CHAIN SECURITY REQUIREMENTS, INCLUDING 21 U.S.C. CH. 9 SUBCH. V. PT. H (RELATING TO PHARMACEUTICAL DISTRIBUTION SUPPLY CHAIN). (F) ELECTRONIC SYSTEM REQUIREMENTS.--A DONATED PRESCRIPTION DRUG SHALL COMPLY WITH APPLICABLE ELECTRONIC SYSTEM REQUIREMENTS CAPABLE OF MAINTAINING A CONTINUOUS CHAIN OF CUSTODY AND AUDITABLE RECORD FOR EACH DONATED PRESCRIPTION DRUG IN COMPLIANCE WITH FEDERAL AND STATE LAW, INCLUDING 21 U.S.C. CH. 9 SUBCH. V. PT. H. RECORDS REQUIRED UNDER THIS SUBSECTION SHALL BE MAINTAINED FOR A PERIOD DETERMINED BY THE BOARD AND SHALL BE MADE AVAILABLE TO THE BOARD UPON REQUEST.

SECTION 6 OF THE ACT IS AMENDED TO READ: Section 6. Immunity. Any person or entity, acting in good faith, who exercises reasonable care in donating, accepting, distributing, dispensing 20250HB0069PN3487 - 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 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.] PROGRAM, INCLUDING LIABILITY FOR FAILURE TO TRANSFER OR COMMUNICATE PRODUCT OR CONSUMER INFO OF THE EXPIRATION DATE OF THE DONATED PRESCRIPTION DRUG. The immunity provided under this section shall not extend to the donation, acceptance, distribution, dispensing or manufacture of the prescription drugs donated PERSON THAT DONATED THE PRESCRIPTION DRUGS to the program if any of the following apply: (1) Damages result from the gross negligence, recklessness or intentional misconduct of the donor. (2) The donor has, or should have, actual or constructive knowledge that the prescription drugs are tainted, contaminated or harmful to the health or well-being of patients participating in the program. Section 2 4. 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. 20250HB0069PN3487 - 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 (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 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) THE QUANTITY AND ESTIMATED VALUE OF PRESCRIPTION DRUGS REDISTRIBUTED UNDER THE PROGRAM. (5) (6) 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. 20250HB0069PN3487 - 9 - <-- <-- 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

LIMITATIONS. NOTWITHSTANDING ANY OTHER PROVISION OF THIS ACT: (1) A CONTROLLED SUBSTANCE MAY NOT BE ACCEPTED, DONATED, DISPENSED, TRANSFERRED, DISTRIBUTED OR REDISTRIBUTED AS PART OF THE PROGRAM. (2) A PRESCRIPTION DRUG THAT REQUIRES THE PRESCRIPTION DRUG BE DISPENSED TO A PATIENT REGISTERED WITH THE DRUG'S MANUFACTURER IN ACCORDANCE WITH FEDERAL FOOD AND DRUG ADMINISTRATION REQUIREMENTS MAY NOT BE ACCEPTED, DONATED, DISPENSED, TRANSFERRED, DISTRIBUTED OR REDISTRIBUTED AS PART OF THE PROGRAM. Section 3 5. 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. The regulations shall include:] (a) Authority.--In order to facilitate the prompt implementation of this act, the board shall promulgate temporary regulations NO LATER THAN DECEMBER 31, 2027, that shall expire no later than three years following the publication of the temporary regulations. 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. 20250HB0069PN3487 - 10 - <-- <-- <--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 (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 DECEMBER 31, 2027 . 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] 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 20250HB0069PN3487 - 11 - <-- <-- <-- <-- 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 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 4 6. 49 Pa. Code §§ 27.501-27.506 shall remain in full force and effect until the publication of the temporary regulations under section 7(a) of this THE act. Section 5 7. This act shall take effect in 60 days. 20250HB0069PN3487 - 12 - <-- <-- <-- 1 2 3 4 5 6 7 8 9