Bill Text: MI HB5231 | 2009-2010 | 95th Legislature | Introduced

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Bill Title: Health; pharmaceuticals; unused prescription drug repository program; create, and allow to distribute to out-of-state charitable repositories. Amends 1978 PA 368 (MCL 333.1101 - 333.25211) by adding sec. 17775.

Spectrum: Partisan Bill (Democrat 1-0)

Status: (Introduced - Dead) 2009-08-11 - Printed Bill Filed 08/05/2009 [HB5231 Detail]

Download: Michigan-2009-HB5231-Introduced.html

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HOUSE BILL No. 5231

 

August 4, 2009, Introduced by Rep. Meadows and referred to the Committee on Health Policy.

 

     A bill to amend 1978 PA 368, entitled

 

"Public health code,"

 

(MCL 333.1101 to 333.25211) by adding section 17775.

 

THE PEOPLE OF THE STATE OF MICHIGAN ENACT:

 

     Sec. 17775. (1) This section may be referred to as the "unused

 

prescription drug repository program".

 

     (2) The board shall establish, implement, and administer a

 

statewide unused prescription drug repository program consistent

 

with public health and safety through which unused prescription

 

drugs, other than controlled substances, may be transferred from a

 

health facility or agency, an adult foster care facility, an

 

assisted living facility, or a manufacturer to a pharmacy or a

 

charitable clinic that elects to participate in the program. The

 

program is created to distribute unused prescription drugs, other

 

than controlled substances, to the medically indigent.

 

     (3) Subject to subsection (11), the board shall promulgate

 

rules and establish procedures necessary to establish, implement,

 

and administer the program. The board shall provide technical

 

assistance to health facilities and agencies, adult foster care

 

facilities, assisted living facilities, manufacturers, pharmacies,

 

and charitable clinics that elect to participate in the program.

 

     (4) Participation in the program by a health facility or

 

agency, adult foster care facility, assisted living facility,

 

manufacturer, pharmacy, or charitable clinic is voluntary. Nothing

 

in this section requires any health facility or agency, adult

 

foster care facility, assisted living facility, manufacturer,

 

pharmacy, or charitable clinic to participate in the program.

 

     (5) Pharmacies, health professionals, and charitable clinics

 

shall use the following criteria in accepting and dispensing unused

 

prescription drugs for use in the program:

 

     (a) Only prescription drugs in their original sealed unit dose

 

packaging or unused injectables shall be accepted and dispensed

 

under the program.

 

     (b) The packaging shall be unopened.

 

     (c) Expired prescription drugs shall not be accepted.

 

     (d) A prescription drug shall not be accepted or dispensed if

 

the person accepting or dispensing the drug has reason to believe

 

that the drug is adulterated.

 

     (e) Controlled substances shall not be accepted.

 

     (f) Subject to the limitations prescribed in this subsection,

 

unused prescription drugs dispensed for purposes of a medical

 

assistance program or drug product donation program may be accepted

 

and dispensed under the program.

 

     (g) Any additional criteria established in rules promulgated

 

under this section.

 

     (6) A pharmacy or charitable clinic that meets the eligibility

 

requirements established by this section and any rules promulgated

 

under this section may do any of the following:

 

     (a) Dispense prescription drugs donated under the program to

 

the medically indigent.

 

     (b) Charge persons receiving donated unused prescription drugs

 

a handling fee established by rule by the board.

 

     (c) Distribute to an out-of-state charitable repository any

 

surplus unused prescription drugs donated under this section.

 

Prescription drugs distributed under this subsection may be

 

repackaged in a manner appropriate for distribution by the pharmacy

 

or charitable clinic.

 

     (7) A pharmacy or charitable clinic that meets the eligibility

 

requirements established by this section and any rules promulgated

 

under this section and that accepts donated unused prescription

 

drugs for the program shall do all of the following:

 

     (a) Comply with all applicable federal laws and regulations

 

and state laws and rules related to the storage and distribution of

 

harmful drugs.

 

     (b) Inspect all donated unused prescription drugs before

 

dispensing the prescription drugs to determine that such drugs are

 

not adulterated.

 

     (c) Dispense prescription drugs only pursuant to a

 

prescription issued by a health professional.

 

     (8) Unused prescription drugs donated under the program shall

 

not be resold. Reimbursement from a governmental agency to a

 

charitable clinic does not constitute resale of prescription drugs.

 

     (9) For purposes of the lawful donation, acceptance, or

 

dispensing of a prescription drug under the program, the following

 

persons that are in compliance with this section and any rules

 

promulgated under this section and in the absence of bad faith or

 

gross negligence are not subject to criminal or civil liability for

 

injury other than death, or loss to person or property, or to

 

professional disciplinary action:

 

     (a) The board.

 

     (b) The department.

 

     (c) A health facility or agency, adult foster care facility,

 

assisted living facility, or manufacturer that donates prescription

 

drugs to the program.

 

     (d) A manufacturer or its representative that directly donates

 

prescription drugs in professional samples to a pharmacy or

 

charitable clinic for the program.

 

     (e) A pharmacy, charitable clinic, or health professional that

 

accepts, dispenses, or distributes prescription drugs for the

 

program.

 

     (f) A pharmacy or charitable clinic that employs a health

 

professional who accepts unused prescription drugs for the program

 

and who may legally dispense prescription drugs under this part.

 

     (10) For purposes of the lawful donation, acceptance, or

 

dispensing of a prescription drug manufactured by the manufacturer

 

that is donated by any entity under the program, a manufacturer is

 

not, in the absence of bad faith or gross negligence, subject to

 

criminal or civil liability for injury other than for death, or

 

loss to person or property, including, but not limited to,

 

liability for failure to transfer or communicate product or

 

consumer information or for failure to transfer or communicate the

 

expiration date of the donated prescription drug.

 

     (11) The board shall promulgate emergency rules under the

 

administrative procedures act of 1969 by October 1, 2009 to

 

establish, implement, and administer the program. Permanent rules

 

shall be promulgated pursuant to the administrative procedures act

 

of 1969 as soon as practical after emergency rules have been

 

promulgated. The department shall include all of the following in

 

rules promulgated under this section:

 

     (a) Eligibility criteria for pharmacies and charitable clinics

 

authorized to receive and dispense donated prescription drugs for

 

the program.

 

     (b) Eligibility criteria for the medically indigent.

 

     (c) Establishment of a formulary that includes all

 

prescription drugs approved by the federal food and drug

 

administration.

 

     (d) Standards and procedures for transfer, acceptance, safe

 

storage, security, and dispensing of donated prescription drugs.

 

     (e) A process for seeking input from the department in

 

establishing provisions that affect health facilities and agencies,

 

adult foster care facilities, and assisted living facilities.

 

     (f) A process for seeking input from the department in

 

establishing provisions that affect mental health and substance

 

abuse clients.

 

     (g) Standards and procedures for inspecting donated

 

prescription drugs to ensure that the prescription drugs meet the

 

requirements of the program and to ensure that, in the professional

 

judgment of the pharmacist, the prescription drugs meet all federal

 

and state standards for product integrity.

 

     (h) Procedures for the destruction or disposal of prescription

 

drugs or other medications that are donated and that are controlled

 

substances or otherwise ineligible for distribution under the

 

program.

 

     (i) Procedures for verifying whether the charitable clinic,

 

pharmacy, responsible pharmacist, or other health professionals

 

participating in the program are licensed and in good standing with

 

the applicable licensing board.

 

     (j) Establishment of standards for acceptance of unused

 

prescription drugs from health facilities and agencies, adult

 

foster care facilities, and assisted living facilities.

 

     (k) Any other standards and procedures the board considers

 

appropriate or necessary to establish, implement, and administer

 

the program.

 

     (12) Pursuant to the rules promulgated and procedures

 

established for the program under this section, a resident of a

 

health facility or agency, adult foster care facility, or assisted

 

living facility, or the representative or guardian of a resident,

 

may donate unused prescription drugs, other than controlled

 

substances, for dispensation to the medically indigent under the

 

program.

 

     (13) This section does not impair or supersede the provisions

 

regarding the cancer drug repository program created in section

 

17780. If any provision of this section conflicts with a provision

 

of that section with regard to cancer drugs, that section controls.

 

     (14) As used in this section:

 

     (a) "Adult foster care facility" means an adult foster care

 

facility licensed under the adult foster care facility licensing

 

act, 1979 PA 218, MCL 400.701 to 400.737.

 

     (b) "Cancer drug" means that term as defined in section 17780.

 

     (c) "Charitable clinic" means a charitable nonprofit

 

corporation or facility that meets all of the following

 

requirements:

 

     (i) Is organized as a not-for-profit corporation pursuant to

 

the nonprofit corporation act, 1982 PA 162, MCL 450.2101 to

 

450.3192.

 

     (ii) Holds a valid exemption from federal income taxation

 

issued pursuant to section 501(a) of the internal revenue code, 26

 

USC 501.

 

     (iii) Is listed as an exempt organization under section 501(c)

 

of the internal revenue code, 26 USC 501.

 

     (iv) Provides on an outpatient basis for a period of less than

 

24 consecutive hours to persons not residing or confined at the

 

facility advice, counseling, diagnosis, treatment, surgery, care,

 

or services relating to the preservation or maintenance of health.

 

     (v) Has a licensed outpatient pharmacy.

 

     (d) "Health facility or agency" means that term as defined in

 

section 20106.

 

     (e) "Health professional" means any of the following

 

individuals licensed and authorized to prescribe and dispense drugs

 

or to provide medical, dental, or other health-related diagnoses,

 

care, or treatment within the scope of his or her professional

 

license:

 

     (i) A physician licensed to practice medicine or osteopathic

 

medicine and surgery under part 170 or 175.

 

     (ii) A registered professional nurse licensed under part 172.

 

     (iii) A physician's assistant licensed under part 170.

 

     (iv) A dentist licensed under part 166.

 

     (v) An optometrist licensed under part 174.

 

     (vi) A pharmacist licensed under this part.

 

     (vii) A podiatrist licensed under part 180.

 

     (f) "Medically indigent" means an individual who meets all of

 

the following requirements:

 

     (i) Is a resident of this state.

 

     (ii) Is eligible to receive medicaid or medicare or has no

 

health insurance and otherwise lacks reasonable means to purchase

 

prescription drugs, as prescribed in rules promulgated under this

 

section.

 

     (g) "Out-of-state charitable repository" means either of the

 

following:

 

     (i) A wholesale distributor that is a bona fide charitable,

 

religious, or nonprofit organization located outside of this state

 

that is an exempt organization under section 501(c)(3) of the

 

internal revenue code, 26 USC 501.

 

     (ii) A foreign medical aid mission group that distributes

 

pharmaceuticals and health care supplies to needy people in foreign

 

countries.

 

     (h) "Program" means the unused prescription drug repository

 

program established under this section.