Bill Text: MI HB5089 | 2011-2012 | 96th Legislature | Engrossed
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-Engrossed.html
HB-5089, As Passed Senate, December 12, 2012
SUBSTITUTE FOR
HOUSE BILL NO. 5089
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 a medical institution as that
term is defined in R 338.486 of the Michigan administrative code.
(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 physician's assistant licensed under part 170, 175, or
180.
(iii) A dentist licensed under part 166.
(iv) An optometrist licensed under part 174.
(v) A pharmacist licensed under this part.
(vi) 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 dispense
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 dispensing 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 for
dispensing. However, prescription drugs packaged in single-unit
dose packaging may be accepted for dispensing even if the outside
packaging is open as long as the single-unit dose packaging is
unopened.
(b) The following shall not be accepted for dispensing:
(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.
(iv) Drugs that can only be dispensed to a patient registered
with the drug's manufacturer under federal food and drug
administration requirements.
(c) A prescription drug shall not be accepted for dispensing
if the person accepting 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 for dispensing 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 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) A manufacturer is not, in the absence of bad faith,
subject to criminal prosecution or liability in tort or other civil
action for injury, death, or loss to person or property for matters
related to the donation, acceptance, or dispensing of a
prescription drug manufactured by the manufacturer that is donated
by any person under the program, including, but not limited to,
liability for failure to transfer or communicate product or
consumer information or 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 list of prescription drugs that are not
eligible for acceptance and dispensing under the program.
(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 community health in establishing
provisions that affect eligible facilities.
(f) A process for seeking input from the department of human
services and the department of community health 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 ineligible for dispensing 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 dispensing 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 dispensing 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 House Bill No. 5090 of the 96th Legislature is enacted into
law.
