Bill Text: MI HB5089 | 2011-2012 | 96th Legislature | Introduced

NOTE: There are more recent revisions of this legislation. Read Latest Draft
Bill Title: Health; pharmaceuticals; unused prescription drug repository and distribution program; create, establish duties relating to the program, provide immunity under certain circumstances, and require the promulgation of rules. Amends 1978 PA 368 (MCL 333.1101 - 333.25211) by adding sec. 17775. TIE BAR WITH: HB 5090'11

Spectrum: Slight Partisan Bill (Republican 12-4)

Status: (Passed) 2012-12-27 - Assigned Pa 383'12 [HB5089 Detail]

Download: Michigan-2011-HB5089-Introduced.html

 

 

 

 

 

 

 

 

 

 

 

 

 

 

HOUSE BILL No. 5089

 

October 18, 2011, Introduced by Reps. Johnson, Ananich, Kurtz, Rendon, Zorn, Huuki, Shirkey, Muxlow, Heise, Hughes, Liss, Hovey-Wright, Lipton, Hooker, Foster and Wayne Schmidt 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 and section 17776 shall be known

 

and may be referred to as the "program for utilization of unused

 

prescription drugs".

 

     (2) As used in this section and section 17776:

 

     (a) "Board" means the Michigan board of pharmacy created under

 

section 17721.

 

     (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) Is organized under or operated as a part of a health

 

facility or agency licensed under article 17.

 

     (v) 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.

 

     (vi) Has a licensed pharmacy.

 

     (d) "Eligible facility" means any of the following:

 

     (i) An adult foster care facility licensed under the adult

 

foster care facility licensing act, 1979 PA 218, MCL 400.701 to

 

400.737.

 

     (ii) An assisted living facility. As used in this subparagraph,

 

"assisted living facility" means any home or establishment

 

offering, coordinating, or providing services to 2 or more

 

individuals who meet the following:

 

     (A) Are domiciled in the home or establishment.

 

     (B) Are not related to the operator of the home or

 

establishment.

 

     (C) By choice or functional impairments, need assistance with

 


personal care or nursing supervision.

 

     (D) May need intermittent or unscheduled nursing care.

 

     (E) May need medication assistance.

 

     (F) May need assistance with transfer or ambulation.

 

     (iii) A health facility or agency, as defined in section 20106.

 

     (e) "Eligible participant" 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.

 

     (f) "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.

 

     (g) "Program" means the statewide unused prescription drug

 

repository and distribution program known as the program for

 


utilization of unused prescription drugs that is established under

 

this section.

 

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

 

statewide unused prescription drug repository and distribution

 

program consistent with public health and safety through which

 

unused or donated prescription drugs, other than controlled

 

substances, may be transferred from an eligible facility or

 

manufacturer to a pharmacy or a charitable clinic that elects to

 

participate in the program. The program is created to distribute

 

unused or donated prescription drugs, other than controlled

 

substances, to eligible participants and to provide for the

 

destruction and disposal of prescription drugs or other medications

 

that are ineligible for distribution under the program.

 

     (4) Participation in the program by an eligible facility,

 

manufacturer, pharmacy, or charitable clinic is voluntary. Nothing

 

in this section or section 17776 requires any eligible facility,

 

manufacturer, pharmacy, or charitable clinic to participate in the

 

program.

 

     (5) Pharmacies, health professionals, and charitable clinics

 

that participate in the program shall use the following criteria in

 

accepting unused or donated prescription drugs from eligible

 

facilities or manufacturers for use in the program:

 

     (a) Only prescription drugs in their original sealed, tamper-

 

evident, and unopened unit dose packaging may be accepted and

 

dispensed. However, prescription drugs packaged in single-unit dose

 

packaging may be accepted and dispensed even if the outside

 

packaging is open as long as the single-unit dose packaging is

 


unopened.

 

     (b) The following shall not be accepted and dispensed:

 

     (i) Expired prescription drugs.

 

     (ii) Controlled substances as defined in article 7 or by

 

federal law.

 

     (iii) Drugs that have been held outside of a health

 

professional's control where sanitation and security cannot be

 

assured.

 

     (c) A prescription drug shall not be accepted and dispensed if

 

the person accepting or dispensing the drug has reason to believe

 

that the drug is adulterated.

 

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

 

unused or donated prescription drugs dispensed for purposes of a

 

medical assistance program or drug product donation program may be

 

accepted and dispensed under the program.

 

     (e) Any additional criteria established in rules promulgated

 

under this section.

 

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

 

requirements for participation in the program and any rules

 

promulgated under this section may do any of the following:

 

     (a) Dispense prescription drugs accepted under the program to

 

eligible participants.

 

     (b) If established by rule under this section, charge eligible

 

participants who receive prescription drugs under the program a

 

handling fee for the service.

 

     (7) A pharmacy or charitable clinic that participates in the

 

program and accepts 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 accepted prescription drugs before dispensing

 

the prescription drugs to determine that the drugs are not

 

adulterated.

 

     (c) Dispense prescription drugs only pursuant to a

 

prescription issued by a health professional.

 

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

 

accepts prescription drugs under the program shall not resell the

 

prescription drugs. Receipt of a fee from an eligible participant,

 

if established in rules promulgated under this section, or

 

reimbursement from a governmental agency to a charitable clinic

 

does not constitute resale of prescription drugs under this

 

subsection.

 

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

 

dispensing of prescription drugs under the program, the following

 

persons that are in compliance with the program, this section and

 

section 17776, 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 professional disciplinary action:

 

     (a) The board.

 

     (b) The department.

 

     (c) An eligible 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 under the program.

 

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

 

accepts or dispenses prescription drugs for the program.

 

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

 

professional who accepts 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 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) Subject to subsection (12), the department, in

 

consultation with the board, shall promulgate rules under the

 

administrative procedures act of 1969 and establish procedures

 

necessary to establish, implement, and administer the program. The

 

board shall provide technical assistance to eligible facilities,

 

manufacturers, pharmacies, and charitable clinics that participate

 

in the program.

 

     (12) The department, in consultation with the board, shall

 

promulgate emergency rules under the administrative procedures act

 

of 1969 on or before the expiration of 6 months after the effective

 


date of this section to establish, implement, and administer the

 

program. The department, in consultation with the board, shall

 

promulgate permanent rules pursuant to the administrative

 

procedures act of 1969 as soon as practical after emergency rules

 

have been promulgated under this subsection. The department and the

 

board shall include all of the following in rules promulgated under

 

this section:

 

     (a) Eligibility criteria for pharmacies and charitable clinics

 

authorized to accept and dispense prescription drugs for the

 

program.

 

     (b) Eligibility criteria for eligible participants.

 

     (c) Establishment of a formulary that includes all

 

prescription drugs approved by the federal food and drug

 

administration.

 

     (d) Standards and procedures for transfer, transportation,

 

acceptance, safe storage, security, and dispensing of prescription

 

drugs.

 

     (e) A process for seeking input from the department of human

 

services and the department of licensing and regulatory affairs in

 

establishing provisions that affect eligible facilities.

 

     (f) A process for seeking input from the department of human

 

services in establishing provisions that affect mental health and

 

substance abuse clients.

 

     (g) Standards and procedures for inspecting accepted

 

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 and environmentally sound

 

disposal of prescription drugs or other medications that are

 

accepted and that are controlled substances or otherwise ineligible

 

for distribution under the program.

 

     (i) Procedures for verifying whether the charitable clinic,

 

pharmacy, 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 or

 

donated prescription drugs from eligible facilities.

 

     (k) Establishment of standards for the acceptance by a

 

pharmacy, health professional, or charitable clinic that

 

participates in the program from any person of a prescription drug

 

or any other medication that is ineligible for distribution under

 

the program for destruction and disposal.

 

     (l) Any other standards and procedures the department, in

 

consultation with the board, considers appropriate or necessary to

 

establish, implement, and administer the program.

 

     (13) Pursuant to the rules promulgated and standards and

 

procedures established for the program under this section, a

 

resident of an eligible facility or the representative or guardian

 

of a resident of an eligible facility may donate unused

 

prescription drugs for dispensing to eligible participants under

 

the program.

 

     (14) Pursuant to rules promulgated and standards and

 

procedures established for the program under this section, a person

 


may deliver to a pharmacy, health professional, or charitable

 

clinic that participates in the program a prescription drug or any

 

other medication that is ineligible for distribution under the

 

program for destruction and disposal.

 

     (15) This section and section 17776 do not impair or supersede

 

the provisions regarding the cancer drug repository program

 

established in section 17780. If any provision of this section or

 

section 17776 conflicts with a provision of section 17780 with

 

regard to a cancer drug, section 17780 controls.

 

     Enacting section 1. This amendatory act does not take effect

 

unless Senate Bill No.____ or House Bill No. 5090(request no.

 

00714'11 **) of the 96th Legislature is enacted into law.

feedback