Cancer Drug Donation Program Act Exposed
The Cancer Drug Donation Program Act was adopted by ALEC's Health and Human Services Task Force on August 5, 2005, amended by the HHS Task Force at the Spring Task Force Summit on May 18, 2008, approved by the ALEC Board of Directors June, 2008. According to ALEC.org, the Act was re-approved by the Board of Directors on January 9, 2014. (Accessed on 2/10/2016).
ALEC Bill Text
Section 1. {Title} This Act shall be known as the “Cancer Drug Donation Program Act.”
Section 2. {Definitions} For purposes of the Cancer Drug Donation Program Act, the following definitions apply:
(1) “Cancer drug” means a prescription drug used to treat cancer or its side effects or used to treat the side effects of a prescription drug used to treat cancer or its side effects. “Cancer drug” does not include drugs for the treatment of cancer that can only be dispensed to a patient registered with the drug manufacturer in accordance with federal Food and Drug Administration requirements;
(2) “Department” means the [insert state agency];
(3) “Donor” means a person, health care facility, hospital, pharmacy, drug manufacturer, medical device manufacturer or supplier, wholesaler of drugs or supplies or any other entity that donates cancer drugs, or supplies needed to administer such drugs, in accordance with this Act;
(4) “Health care facility” means a health care facility licensed in accordance with Section [insert section];
(5) “Health clinic” means a health care clinic licensed in accordance with Section [insert section];
(6) “Hospital” means a facility licensed in accordance with Section [insert section];
(7) “Participant” means a physician’s office, pharmacy, hospital, hospice, or health clinic that has elected to participate in the program and that accepts donated cancer drugs and supplies under the rules and regulations adopted and promulgated by the Department for the Program;
(8) “Pharmacy” means an entity licensed under Section [insert section];
(9) “Physician’s office” means the office of a person licensed to practice medicine and surgery or osteopathic medicine;
(10) “Prescribing practitioner” means a health care practitioner licensed under Sections [insert sections] who is authorized to prescribe cancer drugs;
(11) “Prescription drug” means a drug as defined in Section [insert section];
(12) “Program” means the Cancer Drug Donation Program created by this Act;
(13) “Supplies” means any supplies used in the administration of a cancer drug.
Section 3.
Any person or entity may donate cancer drugs to the Program. Cancer drugs may be donated at a physician’s office, pharmacy, hospital, hospice, or health clinic that elects to participate in the program and meets criteria established by the department for such participation. Cancer drugs will not be donated to a specific cancer patient. No such donated drugs or supplies may be resold by the Program.
Section 4.
The cancer drug or supplies donated to the Program must be prescribed by a practitioner for use by an eligible individual and dispensed by a pharmacist.
Section 5.
(1) A cancer drug or supplies shall only be accepted or dispensed under this Program if such drug is in its original, unopened, sealed, and tamper-evident unit dose packaging, except that a cancer 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) A cancer drug shall not be accepted or dispensed under this Program if such drug bears an expiration date that is no later than [insert length of time] after the date the drug was donated, or if such drug is adulterated or misbranded as determined in paragraph 3 below.
(3) Prior to dispensing to a patient, the cancer drug or supplies donated under this Program must be inspected by a pharmacist to determine that the drug and supplies are not adulterated or misbranded.
(4) Any dispenser of donated products shall not submit a claim or otherwise seek reimbursement from any public and/or private third party payer for donated drugs dispensed to any patient in accordance with this program, and no public or private third party payers shall be required to provide reimbursement for donated drugs dispensed to any patient through this program.
Section 6.
(1) A physician’s office, pharmacy, hospital, hospice, or health clinic that accepts donated cancer drugs under the Program shall comply with all applicable provisions of state and federal law relating to the storage, distribution, and dispensing of such donated cancer drugs.
(2) A physician’s office, pharmacy, hospital, hospice, or health clinic who participates in the Program may charge a nominal handling fee for distributing or dispensing cancer drugs under the Program. Such fee shall be established in rules and regulations adopted and promulgated by the department.
Section 7.
Individuals who meet the eligibility standards for this Cancer Drug Donation Program shall not include patients who are eligible to receive drugs under the state Medicaid Program or under any other prescription drug program funded in whole or in part by the state.
Section 8.
The department, upon the recommendation of the Board of Pharmacy, shall adopt and promulgate rules and regulations to carry out the provisions of this Act. Initial rules and regulations under the Act shall be adopted and promulgated no later than ninety days after the effective date of this Act. Such rules and regulations shall include, but not be limited to:
(1) Eligibility criteria, including a method to determine priority of recipients under this Program.
(2) Standards and procedures for participants that accept, store, distribute or dispense donated cancer drugs or supplies;
(3) Necessary forms for administration of the Program, including, but not limited to, forms for use by persons or entities that donate, accept, distribute, or dispense cancer drugs or supplies under the Program;
(4) The maximum handling fee that may be charged by a participant that accepts and distributes or dispenses donated cancer drugs or supplies;
(5) Categories of cancer drugs and supplies that the Program will accept for dispensing;
(6) Categories of cancer drugs and supplies that the Program will not accept for dispensing and the reason that such drugs and supplies will not be accepted; and
(7) Maintenance and distribution of the participant registry established in Section 8 of this Act.
Section 9.
The department shall establish and maintain a participant registry for the program. The participant registry shall include the participant’s name, address, and telephone number and shall identify whether the participant is a physician’s office, a pharmacy, a hospital, a hospice, or a health clinic. The department shall make the participant registry available to any person or entity wishing to donate cancer drugs to the Program.
Section 10.
Any donor of a cancer drug or supplies, or a participant in the Program who exercises reasonable care in donating, accepting, distributing or dispensing cancer drugs or supplies under the [insert “Cancer Drug Donation Program Act” or name of a similar state program, a Patient Assistance Program, or a Compassionate Use Program] and the rules and regulations adopted and promulgated under the Act, shall be immune from civil or criminal liability and from professional disciplinary action of any kind for any injury, death, or loss to person or property relating to such activities.
Section 11.
No pharmaceutical manufacturer shall be liable for any claim or injury arising from the transfer of any prescription drug pursuant to the provisions of this Act, including but not limited to liability for failure to transfer or communicate product or consumer information regarding the transferred drug, as well as the expiration date of the transferred drug.
Section 12. {Severability Clause}
Section 13. {Repealer Clause}
Section 14. {Effective Date}
Adopted by the Health and Human Services Task Force on August 5, 2005. Amended by the Health and Human Services Task Force at the Spring Task Force Summit on May 18, 2008.
Approved by the ALEC Board of Directors June 2008.
