HB-5672, As Passed Senate, September 13, 2006
SENATE SUBSTITUTE FOR
HOUSE BILL NO. 5672
A bill to amend 1978 PA 368, entitled
"Public health code,"
by amending section 17766 (MCL 333.17766), as amended by 2004 PA
329, and by adding section 17780.
THE PEOPLE OF THE STATE OF MICHIGAN ENACT:
Sec.
17766. Except as provided in section sections 17766d
and 17780, a person who does any of the following is guilty of a
misdemeanor:
(a) Obtains or attempts to obtain a prescription drug by
giving a false name to a pharmacist or other authorized seller,
prescriber, or dispenser.
(b) Obtains or attempts to obtain a prescription drug by
falsely representing that he or she is a lawful prescriber,
dispenser, or licensee, or acting on behalf of a lawful prescriber,
dispenser, or licensee.
(c) Falsely makes, utters, publishes, passes, alters, or
forges a prescription.
(d) Knowingly possesses a false, forged, or altered
prescription.
(e) Knowingly attempts to obtain, obtains, or possesses a drug
by means of a prescription for other than a legitimate therapeutic
purpose, or as a result of a false, forged, or altered
prescription.
(f) Possesses or controls for the purpose of resale, or sells,
offers to sell, dispenses, or gives away, a drug, pharmaceutical
preparation, or chemical that has been dispensed on prescription
and has left the control of a pharmacist.
(g) Possesses or controls for the purpose of resale, or sells,
offers to sell, dispenses, or gives away, a drug, pharmaceutical
preparation, or chemical that has been damaged by heat, smoke,
fire, water, or other cause and is unfit for human or animal use.
(h) Prepares or permits the preparation of a prescription
drug, except as delegated by a pharmacist.
(i) Sells a drug in bulk or in an open package at auction,
unless the sale has been approved in accordance with rules of the
board.
Sec. 17780. (1) The board shall establish and maintain a
cancer drug repository program that would allow a person to donate
a cancer drug or supply for use by an individual who meets the
eligibility criteria specified under subsection (7). The board
shall establish program guidelines, policies, and procedures
addressing the cancer drug repository program. Under the cancer
drug repository program, donations may be made on the premises of a
health facility or pharmacy that elects to participate in the
program and meets the requirements specified under subsection (2).
(2) Any health facility or pharmacy that is licensed and in
compliance with all federal and state laws, rules, and regulations
is eligible to participate in the cancer drug repository program.
Participation in the cancer drug repository program is voluntary
and a pharmacy or health facility may withdraw from participation
in the cancer drug repository program at any time upon notification
to the board. A notice to withdraw from participation may be given
by telephone or regular mail. A pharmacy or health facility may
choose to fully participate in the cancer drug repository program
by accepting, storing, and dispensing or administering donated
drugs and supplies or the pharmacy or health facility may limit its
participation to only accepting and storing donated drugs and
supplies. If a pharmacy or health facility chooses to limit its
participation, the pharmacy or health facility shall distribute any
donated drugs to a fully participating cancer drug repository in
accordance with subsection (8). A pharmacy or health facility that
elects to participate in the cancer drug repository program shall
submit the following information to the board in a form provided by
the board that includes, at a minimum, each of the following:
(a) The name, street address, and telephone number of the
pharmacy or health facility.
(b) The name and telephone number of a pharmacist who is
employed by or under contract with the pharmacy or health facility,
or other contact person who is familiar with the pharmacy's or
health facility's participation in the cancer drug repository
program.
(c) A statement indicating that the pharmacy or health
facility is licensed in this state and in compliance with all
federal and state laws, rules, and regulations and the chosen level
of participation in the cancer drug repository program.
(3) An individual who is at least 18 years of age may donate
legally obtained cancer drugs or supplies to a cancer drug
repository. If the donated drugs have not been previously
dispensed, a pharmacy, health facility, manufacturer, or wholesale
distributor may also donate cancer drugs or supplies to a cancer
drug repository. Donated drugs or supplies are acceptable for
donation if they are determined to be eligible by a pharmacist who
is employed by or under contract with a cancer drug repository as
follows:
(a) A cancer drug is eligible for donation under the cancer
drug repository program only if all of the following requirements
are met:
(i) The donation is accompanied by a cancer drug repository
donor form that is provided by the board and states that to the
best of the donor's knowledge the donated drug has been properly
stored and that the drug has never been opened, used, tampered
with, adulterated, or misbranded. The board shall make the cancer
drug repository donor form available on the board's website. The
form shall be signed by the person making the donation or that
person's authorized representative.
(ii) The drug's expiration date is at least 6 months later than
the date the drug was donated.
(iii) 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.
(iv) The drug is not adulterated or misbranded.
(b) Cancer supplies are eligible for donation under the cancer
drug repository program only if all of the following requirements
are met:
(i) The supplies are not adulterated or misbranded.
(ii) The supplies are in their original, unopened, sealed
package.
(iii) The donation is accompanied by a cancer drug repository
donor form that is provided by the board and states that to the
best of the donor's knowledge the donated supply has been properly
stored and that the supply has never been opened, used, tampered
with, adulterated, or misbranded. The board shall make the cancer
drug repository donor form available on the board's website. The
form shall be signed by the person making the donation or that
person's authorized representative.
(4) Controlled substances are not eligible for donation or
acceptance under the cancer drug repository program. Cancer drugs
and supplies that do not meet the criteria described under
subsection (3) are not eligible for donation or acceptance under
the cancer drug repository program. Cancer drugs and supplies may
be donated on the premises of a cancer drug repository to a
pharmacist designated by the repository. A drop box shall not be
used to deliver or accept donations. Cancer drugs and supplies
donated under the cancer drug repository program shall 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.
(5) Cancer drugs and supplies that are donated under the
cancer drug repository program shall be dispensed by a pharmacist
pursuant to a prescription by a prescriber or may be dispensed or
administered by a dispensing prescriber. The cancer drugs and
supplies shall be visually inspected by the pharmacist or
dispensing prescriber before being dispensed or administered for
adulteration, misbranding, and date of expiration. Cancer 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 or administered.
(6) Before a cancer drug or supply may be dispensed or
administered to an individual, the individual must provide
verification that he or she has a current diagnosis of cancer,
provide proof of his or her insurance, if any, and sign a cancer
drug repository recipient form provided by the board acknowledging
that the individual understands the information stated on the form.
The form shall be made available to the public on the board's
website. The form shall include, at a minimum, the following
information:
(a) That the drug or supply being dispensed or administered
has been donated and may have been previously dispensed.
(b) That a visual inspection has been conducted by the
pharmacist or dispensing prescriber to ensure that the drug has not
expired, has not been adulterated or misbranded, and is in its
original, unopened packaging.
(c) That the pharmacist, the dispensing or administering
prescriber, the cancer drug repository, the board, and any other
participant of the cancer drug repository program cannot guarantee
the safety of the drug or supply being dispensed or administered
and that the pharmacist or prescriber has determined that the drug
or supply is safe to dispense or administer 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 or
prescriber before dispensing or administering.
(7) Any resident of this state who is diagnosed with cancer is
eligible to receive drugs or supplies under the cancer drug
repository program. Cancer drugs and supplies donated under the
cancer drug repository program shall not be resold and shall only
be dispensed or administered to residents of this state who are
diagnosed with cancer. A pharmacist who dispenses those drugs and
supplies donated under the cancer drug repository program shall not
submit a claim or otherwise seek reimbursement from any public or
private third party payer for drugs or supplies dispensed to any
eligible individual in accordance with the program, nor shall a
public or private third party payer be required to provide
reimbursement for donated drugs or supplies dispensed by a
pharmacist to an eligible individual in accordance with the
program. Cancer drugs and supplies dispensed under the cancer drug
repository program shall be dispensed in the following order of
priority:
(a) Individuals who are uninsured or do not have insurance
coverage for those cancer drugs or supplies.
(b) Individuals who are enrolled in medicaid, medicare, or any
other public assistance health care program.
(c) All other individuals who are residents of this state and
diagnosed with cancer.
(8) A cancer drug repository may charge the individual
receiving a drug or supply a handling fee of not more than 250% of
the medicaid dispensing fee or $5.00, whichever is less, for each
cancer drug or supply dispensed or administered. Cancer drug
repositories may distribute drugs and supplies donated under the
cancer drug repository program to other repositories if requested
by a participating repository. 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. If a cancer drug repository distributes
drugs or supplies to another participating repository, the
repository shall complete a cancer drug repository donor form
provided by the board. The completed form and copy of the donor
form that was completed by the original donor under subsection (3)
shall be provided to the fully participating cancer drug repository
at the time of distribution.
(9) Cancer drug repository donor and recipient forms shall be
maintained for at least 5 years. A record of destruction of donated
drugs and supplies that are not dispensed under subsection (7)
shall be maintained by the dispensing repository for at least 5
years. For each drug or supply destroyed, the record shall include
the following information:
(a) The date of destruction.
(b) The name, strength, and quantity of the cancer drug
destroyed.
(c) The name of the person or firm that destroyed the drug.
(d) The source of the drugs or supplies destroyed.
(10) A manufacturer is not subject to criminal liability or
liability in tort or other civil action for injury, death, or loss
to a person or to property for any of the following causes of
action:
(a) The intentional or unintentional adulteration or
misbranding of the drug or supply by a party not under the control
of the manufacturer.
(b) The 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.
(c) Claims for payment to government or private payers.
(11) A health facility or pharmacy participating in the cancer
drug repository program, a pharmacist dispensing a drug or supply
pursuant to the program, a prescriber dispensing or administering a
drug or supply pursuant to the program, or a 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 prescriber as long as the drug or
supply is donated, accepted, distributed, and dispensed according
to 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.
(12) As used in this section:
(a) "Cancer drug" means a prescription drug that is used to
treat either of the following:
(i) Cancer or the side effects of cancer.
(ii) The side effects of any prescription drug that is used to
treat cancer or the side effects of cancer.
(b) "Cancer drug repository" means a health facility or
pharmacy that has notified the board of its election to participate
in the cancer drug repository program.
(c) "Cancer supply" or "supplies" means prescription and
nonprescription cancer supplies needed to administer a cancer drug.
(d) "Distribute" means to deliver, other than by administering
or dispensing.
(e) "Donor" means an individual and not a manufacturer or
wholesale distributor who donates a cancer drug or supply according
to the requirements of the cancer drug repository program.
(f) "Health facility" means a facility licensed in accordance
with article 17 as a county medical care facility, freestanding
surgical outpatient facility, home for the aged, hospital, hospital
long-term care unit, nursing home, and hospice.
(g) "Side effects of cancer" means symptoms of cancer.
(h) "Single unit dose packaging" means a single unit container
for articles intended for administration as a single dose, direct
from the container.
(i) "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.