HB0813ham001 95TH GENERAL ASSEMBLY

Health Care Availability and Access Committee

Filed: 3/6/2007

09500HB0813ham001 LRB095 09713 DRJ 32467 a

AMENDMENT TO HOUSE BILL 813

AMENDMENT NO. ______. Amend House Bill 813 by replacing all of Sections 1 through 35 with the following:

"Section 1. Short title. This Act may be cited as the Cancer Drug Repository Program Act.

Section 5. Definitions. In this Act:

"Cancer drug" means a prescription drug that is used to treat any of the following:

(1) Cancer or side effects of cancer.

(2) The side effects of any prescription drug that is used to treat cancer or side effects of cancer.

"Department" means the Department of Public Health.

"Dispense" has the meaning given to that term in the Pharmacy Practice Act of 1987.

"Pharmacist" means an individual licensed to engage in the practice of pharmacy under the Pharmacy Practice Act of 1987.

"Pharmacy" means a pharmacy registered in this State under the Pharmacy Practice Act of 1987.

"Practitioner" means a person licensed in this State to prescribe and administer drugs or licensed in another state and recognized by this State as a person authorized to prescribe and administer drugs.

"Prescription drug" means any prescribed drug that may be legally dispensed by a pharmacy.

"Program" means the cancer drug repository program established under this Act.

Section 10. Cancer drug repository program. The Department shall establish and maintain a cancer drug repository program, under which any person may donate a cancer drug or supplies needed to administer a cancer drug for use by an individual who meets eligibility criteria specified by the Department in rules. Donations may be made on the premises of a pharmacy that elects to participate in the program and meets requirements specified by the Department in rules. The pharmacy may charge an individual who receives a cancer drug or supplies needed to administer a cancer drug under this Act a handling fee that may not exceed the amount specified by the Department in rules. A pharmacy that receives a donated cancer drug or supplies needed to administer a cancer drug under this Act may distribute the cancer drug or supplies to another eligible pharmacy for use under the program.

Section 15. Requirements for accepting and dispensing cancer drugs and supplies. A cancer drug or supplies needed to administer a cancer drug may be accepted and dispensed under the program only if all of the following requirements are met:

(1) The cancer drug or supplies needed to administer a cancer drug are in their original, unopened, sealed, and tamper-evident unit-dose packaging or, if packaged in single-unit doses, the single-unit-dose packaging is unopened.

(2) The cancer drug bears an expiration date that is later than 6 months after the date that the drug was donated.

(3) The cancer drug or supplies needed to administer a cancer drug are not adulterated or misbranded, as determined by a pharmacist employed by, or under contract with, the pharmacy where the drug or supplies are accepted or dispensed. The pharmacist must inspect the drug or supplies before the drug or supplies are dispensed.

(4) The cancer drug or supplies needed to administer a cancer drug are prescribed by a practitioner for use by an eligible individual.

Section 20. Resale of donated drugs or supplies prohibited. No cancer drug or supplies needed to administer a cancer drug that are donated for use under this Act may be resold.

Section 25. Participation in program not required. Nothing in this Act requires that a pharmacy or pharmacist participate in the cancer drug repository program.

Section 30. Immunity.

(a) Unless the manufacturer's conduct is wilful and wanton, a manufacturer of a drug or supply is not subject to criminal or civil liability for injury, death, or loss to a person or property for matters related to the donation, acceptance, or dispensing of a cancer drug or supply manufactured by the manufacturer that is donated by any person under this Act.

(b) Unless the person's conduct is wilful and wanton, a person is immune from civil liability for injury to or the death of the individual to whom the cancer drug or supply is dispensed and may not be found guilty of unprofessional conduct for his or her acts or omissions related to donating, accepting, distributing, or dispensing a cancer drug or supply under this Act.

Section 35. Rules. The Department shall adopt all of the following as rules:

(1) Requirements for pharmacies to accept and dispense donated cancer drugs or supplies needed to administer cancer drugs under this Act, including all of the following:

(A) Eligibility criteria.

(B) Standards and procedures for accepting, safely storing, and dispensing donated cancer drugs or supplies needed to administer cancer drugs.

(C) Standards and procedures for inspecting donated cancer drugs or supplies needed to administer cancer drugs to determine whether the drugs or supplies are in their original, unopened, sealed, and tamper-evident unit-dose packaging or, if packaged in single-unit doses, the single-unit-dose packaging is unopened.

(D) Standards and procedures for inspecting donated cancer drugs or supplies needed to administer cancer drugs to determine that the drugs or supplies needed to administer cancer drugs are not adulterated or misbranded.

(2) Eligibility criteria for individuals to receive donated cancer drugs or supplies needed to administer cancer drugs dispensed under the cancer drug repository program. The standards shall prioritize dispensation to individuals who are uninsured or indigent but must permit dispensation to others if an uninsured or indigent individual is unavailable.

(3) A means, such as an identification card, by which an individual who is eligible to receive a donated cancer drug or supplies needed to administer a cancer drug may indicate that eligibility.

(4) Necessary forms for administration of the cancer drug repository program, including forms for use by persons that donate, accept, distribute, or dispense cancer drugs or supplies needed to administer cancer drugs under the program.

(5) The maximum handling fee that a pharmacy may charge for accepting, distributing, or dispensing donated cancer drugs or supplies needed to administer cancer drugs.

(6) A list of cancer drugs and supplies needed to administer cancer drugs, arranged by category or by individual cancer drug or supply, that the cancer drug repository program will accept for dispensing.

(7) A list of cancer drugs and supplies needed to administer cancer drugs, arranged by category or by individual cancer drug or supply, that the cancer drug repository program will not accept for dispensing. The list must include a statement that specifies the reason that the drug or supplies are ineligible for donation.

The Department may also adopt any other rules deemed necessary to implement this Act.".