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HB-5672, As Passed House, June 22, 2006

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.

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.

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.

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.

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.

(d) The source of the drugs or supplies destroyed.

(10) A manufacturer is not subject to criminal or civil

liability for injury, death, or loss to a person or to property for

either of the following causes of action:

(a) The intentional or unintentional alteration 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.

(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.

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.