HF 127

as introduced - 84th Legislature (2005 - 2006) Posted on 12/15/2009 12:00am

A bill for an act
relating to health; establishing a cancer drug
repository program; requiring rulemaking; proposing
coding for new law in Minnesota Statutes, chapter 144.

BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF MINNESOTA:

Section 1.

new text begin [144.707] CANCER DRUG REPOSITORY PROGRAM.
new text end

new text begin Subdivision 1. new text end

new text begin Definitions. new text end

new text begin (a) For the purposes of this
section, the terms defined in this subdivision have the meanings
given.
new text end

new text begin (b) "Cancer drug" means a prescription drug that is used to
treat:
new text end

new text begin (1) cancer or the side effects of cancer; or
new text end

new text begin (2) the side effects of any prescription drug that is used
to treat cancer or the side effects of cancer.
new text end

new text begin (c) "Dispense" has the meaning given in section 151.01,
subdivision 30.
new text end

new text begin (d) "Medical facility" means an institution defined in
section 144.50, subdivision 2.
new text end

new text begin (e) "Medical supplies" means any medical supply needed to
administer a cancer drug.
new text end

new text begin (f) "Pharmacist" has the meaning given in section 151.01,
subdivision 3.
new text end

new text begin (g) "Pharmacy" means any pharmacy registered with the Board
of Pharmacy according to section 151.19, subdivision 1.
new text end

new text begin (h) "Practitioner" has the meaning given in section 151.01,
subdivision 23.
new text end

new text begin (i) "Prescription drug" means a legend drug as defined in
section 151.01, subdivision 17.
new text end

new text begin Subd. 2. new text end

new text begin Establishment. new text end

new text begin The commissioner of health shall
establish and maintain a cancer drug repository program, under
which any person may donate a cancer drug or medical supply for
use by an individual who meets eligibility criteria specified by
rule. Under the program, donations may be made on the premises
of a medical facility or pharmacy that elects to participate in
the program and meets the requirements specified by rule. A
medical facility or pharmacy that accepts a donated cancer drug
or supply may dispense the drug or supply to an eligible
individual or may distribute the cancer drug or supply to
another participating medical facility or pharmacy.
new text end

new text begin Subd. 3. new text end

new text begin Requirements to be met. new text end

new text begin A cancer drug or
medical supply may be accepted and dispensed as part of this
program only if the following requirements are met:
new text end

new text begin (1) the cancer drug or medical supply is in its original,
unopened, sealed, and tamper-evident unit dose packaging or, if
packaged in single-unit doses, the single-unit-dose packaging is
unopened;
new text end

new text begin (2) the cancer drug bears an expiration date that is later
than six months after the date that the drug is donated;
new text end

new text begin (3) the cancer drug or supply is not adulterated or
misbranded, as determined by a pharmacist employed by, or under
contract with, the medical facility or pharmacy accepting the
donation. The pharmacist shall inspect the drug or supply
before the drug or supply is dispensed; and
new text end

new text begin (4) the cancer drug or supply is prescribed by a
practitioner for use by an eligible individual and is dispensed
to that individual by a pharmacist.
new text end

new text begin Subd. 4. new text end

new text begin Administration cost. new text end

new text begin No cancer drug or supply
that is donated for use under this section shall be resold. The
medical facility or pharmacy may charge the individual who
receives a cancer drug or supply under the program a handling
fee that may not exceed an amount specified by the commissioner.
new text end

new text begin Subd. 5. new text end

new text begin Participation. new text end

new text begin Nothing in this section requires
that a medical facility, pharmacy, pharmacist, or practitioner
participate in the program.
new text end

new text begin Subd. 6. new text end

new text begin Liability. new text end

new text begin (a) Unless a manufacturer of a drug
or supply exercises bad faith, the manufacturer 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
individual under this section, including liability for failure
to transfer or communicate product or consumer information or
the expiration date of the donated cancer drug or supply.
new text end

new text begin (b) A medical facility, pharmacy, pharmacist, or
practitioner participating in the program is immune from civil
liability for injury to or for the death of an individual to
whom the cancer drug or supply is dispensed and no disciplinary
action shall be taken for unprofessional conduct for acts or
omissions related to donating, accepting, distributing, or
dispensing a cancer drug or supply under this section, unless
the act or omission involves reckless, wanton, or intentional
misconduct.
new text end

new text begin Subd. 7. new text end

new text begin Rules. new text end

new text begin The commissioner shall adopt rules to
implement the program, including:
new text end

new text begin (1) requirements for medical facilities and pharmacies to
accept, distribute, and dispense donated cancer drugs and
supplies under this section, including:
new text end

new text begin (i) eligibility criteria;
new text end

new text begin (ii) standards and procedures for accepting, safely
storing, and dispensing donated cancer drugs and supplies;
new text end

new text begin (iii) standards and procedures for inspecting donated
cancer drugs and supplies to determine if the cancer drug or
supply is in its original, unopened, sealed, and tamper-evident
unit dose packaging or, if packaged in single-unit doses, the
single-unit-dose packaging is unopened; and
new text end

new text begin (iv) standards and procedures for inspecting donated cancer
drugs and supplies to determine that the cancer drug or supply
is not adulterated or misbranded;
new text end

new text begin (2) eligibility criteria for individuals to receive donated
cancer drugs or supplies under the 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;
new text end

new text begin (3) a maximum handling fee that a medical facility or
pharmacy may charge for accepting, distributing, or dispensing
donated cancer drugs or supplies; and
new text end

new text begin (4) a list of cancer drugs and supplies arranged by
category or by individual cancer drug or supply that will be
accepted under the program and a list of cancer drugs and
supplies that will not be accepted under the program. The list
shall include a statement that specifies the reason that a
cancer drug or supply is ineligible for donation.
new text end