HF 127

2nd Engrossment - 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; 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:
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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) "Cancer drug repository" means a medical facility or
pharmacy that has notified the commissioner of its election to
participate in the cancer drug repository program.
new text end

new text begin (d) "Cancer supply" or "supplies" means prescription and
nonprescription cancer supplies needed to administer a cancer
drug.
new text end

new text begin (e) "Commissioner" means the commissioner of health.
new text end

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

new text begin (g) "Distribute" means to deliver, other than by
administering or dispensing.
new text end

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

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

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

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

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

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

new text begin (n) "Side effects of cancer" means symptoms of cancer.
new text end

new text begin (o) "Single-unit-dose packaging" means a single-unit
container for articles intended for administration as a single
dose, direct from the container.
new text end

new text begin (p) "Tamper-evident unit dose packaging" means a container
within which a drug is sealed so that the contents cannot be
opened without obvious destruction of the seal.
new text end

new text begin Subd. 2. new text end

new text begin Establishment. new text end

new text begin The commissioner shall establish
and maintain a cancer drug repository program under which any
person may donate a cancer drug or supply for use by an
individual who meets the eligibility criteria specified under
subdivision 4. 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
under subdivision 3.
new text end

new text begin Subd. 3. new text end

new text begin Requirements for participation by pharmacies and
medical facilities. new text end

new text begin (a) To be eligible for participation in the
cancer drug repository program, a pharmacy or medical facility
must be licensed and in compliance with all applicable federal
and state laws and administrative rules.
new text end

new text begin (b) Participation in the cancer drug repository program is
voluntary. A pharmacy or medical facility may elect to
participate in the cancer drug repository program by submitting
the following information to the commissioner, in a form
provided by the commissioner:
new text end

new text begin (1) the name, street address, and telephone number of the
pharmacy or medical facility;
new text end

new text begin (2) the name and telephone number of a pharmacist who is
employed by or under contract with the pharmacy or medical
facility, or other contact person who is familiar with the
pharmacy's or medical facility's participation in the cancer
drug repository program; and
new text end

new text begin (3) a statement indicating that the pharmacy or medical
facility meets the eligibility requirements under paragraph (a)
and the chosen level of participation under paragraph (c).
new text end

new text begin (c) A pharmacy or medical facility may fully participate in
the cancer drug repository program by accepting, storing, and
dispensing donated drugs and supplies, or may limit its
participation to only accepting and storing donated drugs and
supplies. If a pharmacy or facility chooses to limit its
participation, the pharmacy or facility shall distribute any
donated drugs to a fully participating cancer drug repository in
accordance with subdivision 8.
new text end

new text begin (d) A pharmacy or medical facility may withdraw from
participation in the cancer drug repository program at any time
upon notification to the commissioner. A notice to withdraw
from participation may be given by telephone or regular mail.
new text end

new text begin Subd. 4. new text end

new text begin Individual eligibility requirements. new text end

new text begin Any
Minnesota resident who is diagnosed with cancer is eligible to
receive drugs or supplies under the cancer drug repository
program. Drugs and supplies shall be dispensed according to the
priority given under subdivision 6.
new text end

new text begin Subd. 5. new text end

new text begin Donations of cancer drugs and supplies. new text end

new text begin (a) Any
one of the following persons may donate legally obtained cancer
drugs or supplies to a cancer drug repository if the drugs or
supplies meet the requirements under paragraph (b) or (c) as
determined by a pharmacist who is employed by or under contract
with a cancer drug repository:
new text end

new text begin (1) an individual who is 18 years of age or older; or
new text end

new text begin (2) a pharmacy, medical facility, drug manufacturer, or
wholesale drug distributor, if the donated drugs have not been
previously dispensed.
new text end

new text begin (b) A cancer drug is eligible for donation under the cancer
drug repository program only if the following requirements are
met:
new text end

new text begin (1) the donation is accompanied by a cancer drug repository
donor form described under paragraph (d) that is signed by the
person making the donation or that person's authorized
representative;
new text end

new text begin (2) the drug's expiration date is at least six months later
than the date that the drug was donated;
new text end

new text begin (3) the drug is in its original, unopened, tamper-evident
unit dose packaging that includes the drug's lot number and
expiration date. Single-unit dose drugs may be accepted if the
single-unit-dose packaging is unopened; and
new text end

new text begin (4) the drug is not adulterated or misbranded.
new text end

new text begin (c) Cancer supplies are eligible for donation under the
cancer drug repository program only if the following
requirements are met:
new text end

new text begin (1) the supplies are not adulterated or misbranded;
new text end

new text begin (2) the supplies are in their original, unopened, sealed
packaging; and
new text end

new text begin (3) the donation is accompanied by a cancer drug repository
donor form described under paragraph (d) that is signed by the
person making the donation or that person's authorized
representative.
new text end

new text begin (d) The cancer drug repository donor form must be provided
by the commissioner and shall state that to the best of the
donor's knowledge the donated drug or supply has been properly
stored and that the drug or supply has never been opened, used,
tampered with, adulterated, or misbranded. The commissioner
shall make the cancer drug repository donor form available on
the Department of Health's Web site.
new text end

new text begin (e) Controlled substances and drugs and supplies that do
not meet the criteria under this subdivision are not eligible
for donation or acceptance under the cancer drug repository
program.
new text end

new text begin (f) Drugs and supplies may be donated on the premises of a
cancer drug repository to a pharmacist designated by the
repository. A drop box may not be used to deliver or accept
donations.
new text end

new text begin (g) Cancer drugs and supplies donated under the cancer drug
repository program must be stored in a secure storage area under
environmental conditions appropriate for the drugs or supplies
being stored. Donated drugs and supplies may not be stored with
nondonated inventory.
new text end

new text begin Subd. 6. new text end

new text begin Dispensing requirements. new text end

new text begin (a) Drugs and supplies
must be dispensed by a licensed pharmacist pursuant to a
prescription by a practitioner and in accordance with the
requirements of chapter 151.
new text end

new text begin (b) Before being dispensed, cancer drugs and supplies shall
be visually inspected by the pharmacist for adulteration,
misbranding, and date of expiration. Drugs or supplies that
have expired or appear upon visual inspection to be adulterated,
misbranded, or tampered with in any way may not be dispensed.
new text end

new text begin (c) Before a cancer drug or supply may be dispensed to an
individual, the individual must sign a cancer drug repository
recipient form provided by the commissioner acknowledging that
the individual understands the information stated on the form.
The form shall include the following information:
new text end

new text begin (1) that the drug or supply being dispensed has been
donated and may have been previously dispensed;
new text end

new text begin (2) that a visual inspection has been conducted by the
pharmacist to ensure that the drug has not expired, has not been
adulterated or misbranded, and is in its original, unopened
packaging; and
new text end

new text begin (3) that the dispensing pharmacist, the cancer drug
repository, the Department of Health, and any other participant
in the cancer drug repository program cannot guarantee the
safety of the drug or supply being dispensed and that the
pharmacist has determined that the drug or supply is safe to
dispense based on the accuracy of the donor's form submitted
with the donated drug or supply and the visual inspection
required to be performed by the pharmacist before dispensing.
new text end

new text begin The commissioner shall make the cancer drug repository form
available on the Department of Health's Web site.
new text end

new text begin (d) Drugs and supplies shall only be dispensed to
individuals who meet the eligibility requirements in subdivision
4 and in the following order of priority:
new text end

new text begin (1) individuals who are uninsured;
new text end

new text begin (2) individuals who are enrolled in medical assistance,
general assistance medical care, MinnesotaCare, Medicare, or
other public assistance health care; and
new text end

new text begin (3) all other individuals who are otherwise eligible under
subdivision 4 to receive drugs or supplies from a cancer drug
repository.
new text end

new text begin Subd. 7. new text end

new text begin Handling fees. new text end

new text begin A cancer drug repository may
charge the individual receiving a drug or supply a handling fee
of no more than 250 percent of the medical assistance program
dispensing fee for each cancer drug or supply dispensed.
new text end

new text begin Subd. 8. new text end

new text begin Distribution of donated cancer drugs and
supplies. new text end

new text begin (a) Cancer drug repositories may distribute drugs and
supplies donated under the cancer drug repository program to
other repositories if requested by a participating repository.
new text end

new text begin (b) A cancer drug repository that has elected not to
dispense donated drugs or supplies shall distribute any donated
drugs and supplies to a participating repository upon request of
the repository.
new text end

new text begin (c) If a cancer drug repository distributes drugs or
supplies under paragraph (a) or (b), the repository shall
complete a cancer drug repository donor form provided by the
commissioner. The completed form and a copy of the donor form
that was completed by the original donor under subdivision 5
shall be provided to the fully participating cancer drug
repository at the time of distribution.
new text end

new text begin Subd. 9. new text end

new text begin Resale of donated drugs or supplies. new text end

new text begin Donated
drugs and supplies may not be resold.
new text end

new text begin Subd. 10. new text end

new text begin Record-keeping requirements. new text end

new text begin (a) Cancer drug
repository donor and recipient forms shall be maintained for at
least five years.
new text end

new text begin (b) A record of destruction of donated drugs and supplies
that are not dispensed under subdivision 6 shall be maintained
by the dispensing repository for at least five years. For each
drug or supply destroyed, the record shall include the following
information:
new text end

new text begin (1) the date of destruction;
new text end

new text begin (2) the name, strength, and quantity of the cancer drug
destroyed;
new text end

new text begin (3) the name of the person or firm that destroyed the drug;
and
new text end

new text begin (4) the source of the drugs or supplies destroyed.
new text end

new text begin Subd. 11. new text end

new text begin Liability. new text end

new text begin (a) The manufacturer of a drug or
supply is not subject to criminal or civil liability for injury,
death, or loss to a person or to property related to the
donation of one of its drugs and caused by:
new text end

new text begin (1) the intentional or unintentional alteration of the drug
or supply by a party not under the control of the manufacturer;
or
new text end

new text begin (2) failure of a party not under the control of the
manufacturer to transfer or communicate product or consumer
information or the expiration date of the donated drug or supply.
new text end

new text begin (b) A medical facility or pharmacy participating in the
program, a pharmacist dispensing a drug or supply pursuant to
the program, a practitioner administering a drug or supply
pursuant to the program, or the donor of a cancer drug or supply
is immune from civil liability for an act or omission that
causes injury to or the death of an individual to whom the
cancer drug or supply is dispensed and no disciplinary action
shall be taken against a pharmacist or practitioner so long as
the drug or supply is donated, accepted, distributed, and
dispensed in accordance with the requirements of this section.
This immunity does not apply if the act or omission involves
reckless, wanton, or intentional misconduct, or malpractice
unrelated to the quality of the cancer drug or supply.
new text end