Health Care Availability and Access Committee

Filed: 3/6/2007

 

 


 

 


 
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1
AMENDMENT TO HOUSE BILL 813

2     AMENDMENT NO. ______. Amend House Bill 813 by replacing all
3 of Sections 1 through 35 with the following:
 
4     "Section 1. Short title. This Act may be cited as the
5 Cancer Drug Repository Program Act.
 
6     Section 5. Definitions. In this Act:
7     "Cancer drug" means a prescription drug that is used to
8 treat any of the following:
9         (1) Cancer or side effects of cancer.
10         (2) The side effects of any prescription drug that is
11     used to treat cancer or side effects of cancer.
12     "Department" means the Department of Public Health.
13     "Dispense" has the meaning given to that term in the
14 Pharmacy Practice Act of 1987.
15     "Pharmacist" means an individual licensed to engage in the
16 practice of pharmacy under the Pharmacy Practice Act of 1987.

 

 

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1     "Pharmacy" means a pharmacy registered in this State under
2 the Pharmacy Practice Act of 1987.
3     "Practitioner" means a person licensed in this State to
4 prescribe and administer drugs or licensed in another state and
5 recognized by this State as a person authorized to prescribe
6 and administer drugs.
7     "Prescription drug" means any prescribed drug that may be
8 legally dispensed by a pharmacy.
9     "Program" means the cancer drug repository program
10 established under this Act.
 
11     Section 10. Cancer drug repository program. The Department
12 shall establish and maintain a cancer drug repository program,
13 under which any person may donate a cancer drug or supplies
14 needed to administer a cancer drug for use by an individual who
15 meets eligibility criteria specified by the Department in
16 rules. Donations may be made on the premises of a pharmacy that
17 elects to participate in the program and meets requirements
18 specified by the Department in rules. The pharmacy may charge
19 an individual who receives a cancer drug or supplies needed to
20 administer a cancer drug under this Act a handling fee that may
21 not exceed the amount specified by the Department in rules. A
22 pharmacy that receives a donated cancer drug or supplies needed
23 to administer a cancer drug under this Act may distribute the
24 cancer drug or supplies to another eligible pharmacy for use
25 under the program.
 

 

 

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1     Section 15. Requirements for accepting and dispensing
2 cancer drugs and supplies. A cancer drug or supplies needed to
3 administer a cancer drug may be accepted and dispensed under
4 the program only if all of the following requirements are met:
5         (1) The cancer drug or supplies needed to administer a
6     cancer drug are in their original, unopened, sealed, and
7     tamper-evident unit-dose packaging or, if packaged in
8     single-unit doses, the single-unit-dose packaging is
9     unopened.
10         (2) The cancer drug bears an expiration date that is
11     later than 6 months after the date that the drug was
12     donated.
13         (3) The cancer drug or supplies needed to administer a
14     cancer drug are not adulterated or misbranded, as
15     determined by a pharmacist employed by, or under contract
16     with, the pharmacy where the drug or supplies are accepted
17     or dispensed. The pharmacist must inspect the drug or
18     supplies before the drug or supplies are dispensed.
19         (4) The cancer drug or supplies needed to administer a
20     cancer drug are prescribed by a practitioner for use by an
21     eligible individual.
 
22     Section 20. Resale of donated drugs or supplies prohibited.
23 No cancer drug or supplies needed to administer a cancer drug
24 that are donated for use under this Act may be resold.
 

 

 

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1     Section 25. Participation in program not required. Nothing
2 in this Act requires that a pharmacy or pharmacist participate
3 in the cancer drug repository program.
 
4     Section 30. Immunity.
5     (a) Unless the manufacturer's conduct is wilful and wanton,
6 a manufacturer of a drug or supply is not subject to criminal
7 or civil liability for injury, death, or loss to a person or
8 property for matters related to the donation, acceptance, or
9 dispensing of a cancer drug or supply manufactured by the
10 manufacturer that is donated by any person under this Act.
11     (b) Unless the person's conduct is wilful and wanton, a
12 person is immune from civil liability for injury to or the
13 death of the individual to whom the cancer drug or supply is
14 dispensed and may not be found guilty of unprofessional conduct
15 for his or her acts or omissions related to donating,
16 accepting, distributing, or dispensing a cancer drug or supply
17 under this Act.
 
18     Section 35. Rules. The Department shall adopt all of the
19 following as rules:
20         (1) Requirements for pharmacies to accept and dispense
21     donated cancer drugs or supplies needed to administer
22     cancer drugs under this Act, including all of the
23     following:

 

 

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1             (A) Eligibility criteria.
2             (B) Standards and procedures for accepting, safely
3         storing, and dispensing donated cancer drugs or
4         supplies needed to administer cancer drugs.
5             (C) Standards and procedures for inspecting
6         donated cancer drugs or supplies needed to administer
7         cancer drugs to determine whether the drugs or supplies
8         are in their original, unopened, sealed, and
9         tamper-evident unit-dose packaging or, if packaged in
10         single-unit doses, the single-unit-dose packaging is
11         unopened.
12             (D) Standards and procedures for inspecting
13         donated cancer drugs or supplies needed to administer
14         cancer drugs to determine that the drugs or supplies
15         needed to administer cancer drugs are not adulterated
16         or misbranded.
17         (2) Eligibility criteria for individuals to receive
18     donated cancer drugs or supplies needed to administer
19     cancer drugs dispensed under the cancer drug repository
20     program. The standards shall prioritize dispensation to
21     individuals who are uninsured or indigent but must permit
22     dispensation to others if an uninsured or indigent
23     individual is unavailable.
24         (3) A means, such as an identification card, by which
25     an individual who is eligible to receive a donated cancer
26     drug or supplies needed to administer a cancer drug may

 

 

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1     indicate that eligibility.
2         (4) Necessary forms for administration of the cancer
3     drug repository program, including forms for use by persons
4     that donate, accept, distribute, or dispense cancer drugs
5     or supplies needed to administer cancer drugs under the
6     program.
7         (5) The maximum handling fee that a pharmacy may charge
8     for accepting, distributing, or dispensing donated cancer
9     drugs or supplies needed to administer cancer drugs.
10         (6) A list of cancer drugs and supplies needed to
11     administer cancer drugs, arranged by category or by
12     individual cancer drug or supply, that the cancer drug
13     repository program will accept for dispensing.
14         (7) A list of cancer drugs and supplies needed to
15     administer cancer drugs, arranged by category or by
16     individual cancer drug or supply, that the cancer drug
17     repository program will not accept for dispensing. The list
18     must include a statement that specifies the reason that the
19     drug or supplies are ineligible for donation.
20     The Department may also adopt any other rules deemed
21 necessary to implement this Act.".